Astoria Pacific Inc

FDA Filings

This page includes the latest FDA filings for Astoria Pacific Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3050015
• FEI Number: 3050015
• Name: ASTORIA-PACIFIC,INC.
• Owner & Operator: ASTORIA-PACIFIC, INC.
• Contact Address: 15130 S.E. 82ND DR. ; Clackamas OR 97015 US
• Official Correspondent:
  • Jason C Adams
  • x-503-6573010-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 15130 S.E. 82ND DR. ; Clackamas, OR 97015 US
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00725609000649 ASTORIA-PACIFIC, INC.	SPOTCHECK 85-4000-05K	2020-12-25
GUDID 00725609000625 ASTORIA-PACIFIC, INC.	SPOTCHECK 85-2000-05K	2020-12-25
GUDID 00725609000618 ASTORIA-PACIFIC, INC.	SPOTCHECK 85-1000-05K	2020-12-25
GUDID 00725609000601 ASTORIA-PACIFIC, INC.	SPOTCHECK 81-1100-05K	2020-12-25
GUDID 00725609000595 ASTORIA-PACIFIC, INC.	SPOTCHECK 81-2500-05K	2020-12-25
GUDID 00725609000526 ASTORIA-PACIFIC, INC.	SPOTCHECK 82-0200P6K	2020-12-25
GUDID 00725609000489 ASTORIA-PACIFIC, INC.	SPOTCHECK 82-0202-01K	2020-12-25
GUDID 00725609000472 ASTORIA-PACIFIC, INC.	SPOTCHECK 82-0200-01K	2020-12-25
GUDID 00725609000465 ASTORIA-PACIFIC, INC.	SPOTCHECK 82-0201-01K	2020-12-25
GUDID 00725609000267 ASTORIA-PACIFIC, INC.	SPOTCHECK 910-0500-00	2019-12-23
PMN K182141 | OHQ ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK? MS/MS Blood Spot Controls	2018-10-12
GUDID 00725609000519 ASTORIA-PACIFIC, INC.	SPOTCHECK 361-A803-00	2018-07-06
GUDID 00725609000502 ASTORIA-PACIFIC, INC.	SPOTCHECK 303-A980-00B	2018-07-06
GUDID 00725609000496 ASTORIA-PACIFIC, INC.	SPOTCHECK 303-A980-00A	2018-07-06
GUDID 00725609000458 ASTORIA-PACIFIC, INC.	SPOTCHECK 80-0901-01K	2018-07-06
GUDID 00725609000441 ASTORIA-PACIFIC, INC.	SPOTCHECK 80-0900P4K	2018-07-06
GUDID 00725609000434 ASTORIA-PACIFIC, INC.	SPOTCHECK 307-C001-00	2018-07-06
GUDID 00725609000427 ASTORIA-PACIFIC, INC.	SPOTCHECK 307-A001-03	2018-07-06
GUDID 00725609000410 ASTORIA-PACIFIC, INC.	SPOTCHECK 307-A001-02	2018-07-06
GUDID 00725609000403 ASTORIA-PACIFIC, INC.	SPOTCHECK 307-A001-01	2018-07-06
GUDID 00725609000397 ASTORIA-PACIFIC, INC.	SPOTCHECK 315-A110-VS2	2018-07-06
GUDID 00725609000380 ASTORIA-PACIFIC, INC.	SPOTCHECK 307-A980-00B	2018-07-06
GUDID 00725609000373 ASTORIA-PACIFIC, INC.	SPOTCHECK 307-A980-00A	2018-07-06
GUDID 00725609000366 ASTORIA-PACIFIC, INC.	SPOTCHECK 307-A950-04	2018-07-06
GUDID 00725609000359 ASTORIA-PACIFIC, INC.	SPOTCHECK 307-A950-00	2018-07-06
GUDID 00725609000342 ASTORIA-PACIFIC, INC.	SPOTCHECK 307-A990-00	2018-07-06
GUDID 00725609000335 ASTORIA-PACIFIC, INC.	SPOTCHECK 315-A995-00	2018-07-06
GUDID 00725609000328 ASTORIA-PACIFIC, INC.	SPOTCHECK 303-A004-03	2018-07-06
GUDID 00725609000311 ASTORIA-PACIFIC, INC.	SPOTCHECK 303-A003-03	2018-07-06
GUDID 00725609000304 ASTORIA-PACIFIC, INC.	SPOTCHECK 303-A002-03	2018-07-06
GUDID 00725609000298 ASTORIA-PACIFIC, INC.	SPOTCHECK 303-A000-03	2018-07-06
GUDID 00725609000281 ASTORIA-PACIFIC, INC.	SPOTCHECK 302-A100-03EX	2018-07-06
GUDID 00725609000274 ASTORIA-PACIFIC, INC.	SPOTCHECK 302-A100-03	2018-07-06
GUDID 00725609000250 ASTORIA-PACIFIC, INC.	SPOTCHECK 80-8060P10K	2018-07-06
GUDID 00725609000243 ASTORIA-PACIFIC, INC.	SPOTCHECK 80-8065P10K	2018-07-06
GUDID 00725609000236 ASTORIA-PACIFIC, INC.	SPOTCHECK 80-8065-75K	2018-07-06
GUDID 00725609000229 ASTORIA-PACIFIC, INC.	SPOTCHECK 80-8060-75K	2018-07-06
GUDID 00725609000212 ASTORIA-PACIFIC, INC.	SPOTCHECK 80-0901P4K	2018-07-06
GUDID 00725609000205 ASTORIA-PACIFIC, INC.	SPOTCHECK 80-0900-01K	2018-07-06
GUDID 00725609000199 ASTORIA-PACIFIC, INC.	Accuwell 6020-20-EGAL	2018-07-06
GUDID 00725609000182 ASTORIA-PACIFIC, INC.	SPOTCHECK 80-4065P10K	2018-07-06
GUDID 00725609000175 ASTORIA-PACIFIC, INC.	SPOTCHECK 80-4065-75K	2018-07-06
GUDID 00725609000168 ASTORIA-PACIFIC, INC.	SPOTCHECK 80-4060P10K	2018-07-06
GUDID 00725609000151 ASTORIA-PACIFIC, INC.	SPOTCHECK 80-4060-75K	2018-07-06
GUDID 00725609000144 ASTORIA-PACIFIC, INC.	SPOTCHECK 81-8000-60K	2018-07-06
GUDID 00725609000137 ASTORIA-PACIFIC, INC.	SPOTCHECK 81-8000-13K	2018-07-06
GUDID 00725609000120 ASTORIA-PACIFIC, INC.	SPOTCHECK 81-4000-60K	2018-07-06
GUDID 00725609000113 ASTORIA-PACIFIC, INC.	SPOTCHECK 81-4000-20K	2018-07-06
GUDID 00725609000106 ASTORIA-PACIFIC, INC.	SPOTCHECK 81-2000-60K	2018-07-06
GUDID 00725609000090 ASTORIA-PACIFIC, INC.	SPOTCHECK 81-2000-20K	2018-07-06
GUDID 00725609000083 ASTORIA-PACIFIC, INC.	SPOTCHECK 80-8000-CA	2018-07-06
GUDID 00725609000076 ASTORIA-PACIFIC, INC.	SPOTCHECK 80-8000-13K	2018-07-06
GUDID 00725609000069 ASTORIA-PACIFIC, INC.	SPOTCHECK 80-4500-13K	2018-07-06
GUDID 00725609000052 ASTORIA-PACIFIC, INC.	SPOTCHECK 80-4000-CA	2018-07-06
GUDID 00725609000045 ASTORIA-PACIFIC, INC.	SPOTCHECK 80-4000-13K	2018-07-06
GUDID 00725609000038 ASTORIA-PACIFIC, INC.	SPOTCHECK 80-3500-13K	2018-07-06
GUDID 00725609000021 ASTORIA-PACIFIC, INC.	SPOTCHECK 80-3000-13K	2018-07-06
GUDID 00725609000014 ASTORIA-PACIFIC, INC.	SPOTCHECK 80-2000-13K	2018-07-06
GUDID 00725609000007 ASTORIA-PACIFIC, INC.	SPOTCHECK 80-1000-13	2018-07-06
PMN K972974 | KLI ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK T4 Neonatal Screening Kit	2016-07-12
PMN K972974 | KLI ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	PRIME T4 Neonatal Screening EIA	2016-07-12
PMN K972974 | KLI ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	BioDominium Diagnostics T4 Neonatal Screening EIA	2016-07-12
PMN K972974 | KLI ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	Accuwell T4 Neonatal Screening EIA	2016-07-12
PMN K060452 | JLX ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK 17-OHP Neonatal Screening Kit	2016-07-12
PMN K060452 | JLX ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	PRIME 17-OHP Neonatal Screening EIA	2016-07-12
PMN K060452 | JLX ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	BioDominium Diagnostics 17-OHP Neonatal Screening EIA	2016-07-12
PMN K060452 | JLX ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	Accuwell 17-OHP Neonatal Screening EIA	2016-07-12
PMN K001455 | JLW ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK TSH Neonatal Screening Kit	2016-07-12
PMN K001455 | JLW ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	PRIME TSH Neonatal Screening ELISA	2016-07-12
PMN K001455 | JLW ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	BioDominium Diagnostics TSH Neonatal Screening ELISA	2016-07-12
PMN K001455 | JLW ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	Accuwell TSH Neonatal Screening ELISA	2016-07-12
PMN K121101 | JIA ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Neonatal Total Galactose Microplate Reagent Kit	2013-10-23
PMN K121101 ASTORIA-PACIFIC,INC.	SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT	2013-06-20
PMN K991498 | JIA ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Total Galactose Neonatal Screening Kit	2013-02-07
PMN K991498 | JIA ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	PRIME Total Galactose Neonatal Screening Kit	2013-02-07
PMN K991498 | JIA ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	BioDominium Diagnostics Total Galactose Neonatal Screening Kit	2013-02-07
PMN K991498 | JIA ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	Accuwell Total Galactose Neonatal Screening Kit	2013-02-07
PMN K974047 | JNB ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Phenylalanine Neonatal Screening Kit	2013-02-07
PMN K974047 | JNB ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	PRIME Phenylalanine Neonatal Screening Kit	2013-02-07
PMN K974047 | JNB ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	BioDominium Diagnostics Phenylalanine Neonatal Screening Kit	2013-02-07
PMN K974047 | JNB ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	Accuwell Phenylalanine Neonatal Screening Kit	2013-02-07
PMN K102643 | KQP ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Pro	2011-10-07
PMN K102643 | KQP ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Neonatal GALT Microplate Rgt Kit	2011-10-07
PMN K102643 | JJQ ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Pro	2011-10-07
PMN K102643 | JJQ ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Neonatal GALT Microplate Rgt Kit	2011-10-07
PMN K101392 | NAK ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Flow	2011-10-07
PMN K101392 | NAK ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	NeoPac Software	2011-10-07
PMN K101392 | NAK ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	307 Digitial Fluorometer/Photometer	2011-10-07
PMN K101392 | KQP ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Flow	2011-10-07
PMN K101392 | KQP ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	NeoPac Software	2011-10-07
PMN K101392 | KQP ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	307 Digitial Fluorometer/Photometer	2011-10-07
PMN K101392 | JNB ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Flow	2011-10-07
PMN K101392 | JNB ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	NeoPac Software	2011-10-07
PMN K101392 | JNB ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	307 Digitial Fluorometer/Photometer	2011-10-07
PMN K101392 | JJC ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Flow	2011-10-07
PMN K101392 | JJC ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	NeoPac Software	2011-10-07
PMN K101392 | JJC ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	307 Digitial Fluorometer/Photometer	2011-10-07
PMN K101392 | JIA ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Flow	2011-10-07
PMN K101392 | JIA ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	NeoPac Software	2011-10-07
PMN K101392 | JIA ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	307 Digitial Fluorometer/Photometer	2011-10-07
PMN K101392 | JBL ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Flow	2011-10-07
PMN K101392 | JBL ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	NeoPac Software	2011-10-07
PMN K101392 | JBL ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	307 Digitial Fluorometer/Photometer	2011-10-07
PMN K101392 | CDR ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Flow	2011-10-07
PMN K101392 | CDR ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	NeoPac Software	2011-10-07
PMN K101392 | CDR ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	307 Digitial Fluorometer/Photometer	2011-10-07
PMN K102643 ASTORIA-PACIFIC,INC.	SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT	2011-07-15
PMN K101392 ASTORIA-PACIFIC,INC.	NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D	2011-02-04
PMN K090940 | JJT ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	Astoria-Pacific SPOTCHECK Blood Spot Controls	2010-11-22
PMN K890332 | JJC ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Analyzer	2010-04-19
PMN K883020 | JJF ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Analyzer	2010-04-16
PMN K851542 | JJF ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Analyzer	2010-04-16
PMN K090940 ASTORIA-PACIFIC,INC.	SPOTCHECK BLOOD SPOT CONTROL, ASSAYED	2009-12-14
PMN K080294 | NAK ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Biotinidase Plate Rgt Kit	2009-11-09
PMN K080294 ASTORIA-PACIFIC,INC.	ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT	2008-11-04
PMN K990957 | JBL ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK G6PD 50 hour kit	2007-11-09
PMN K970277 | KQP ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Uridyltransferase 50 hour	2007-11-09
PMN K970093 | CDR ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Tyrosine 50 hour kit	2007-11-09
PMN K894011 | KQP ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Total Galactose 50 hr kit	2007-11-09
PMN K891070 | JNB ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Phenylalanine 50 hour kit	2007-11-09
PMN K010844 | NAK ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Biotinidase 50 hour kit	2007-11-09
PMN K010844 ASTORIA-PACIFIC,INC.	ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K	2001-09-21
PMN K990957 ASTORIA-PACIFIC,INC.	ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K	1999-05-11
PMN K970093 ASTORIA-PACIFIC,INC.	TYROSINE 50-HOUR REAGENT KIT	1998-03-19
PMN K970277 ASTORIA-PACIFIC,INC.	URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)	1997-12-11
JJC ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	SPOTCHECK Neonatal Screening System	1992-07-01
JJC ASTORIA-PACIFIC,INC. [ASTORIA-PACIFIC, INC.]	MULTI-LAB ANALYZER	1992-07-01

Related Finance Registrations

NCAGE Code	1SZD1	ASTORIA-PACIFIC, INC.
CAGE Code	1SZD1	ASTORIA-PACIFIC, INC.
S.A.M. Registration	1SZD1 [623238615]	ASTORIA-PACIFIC, INC.