Polymedco Inc

FDA Filings

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

Polymedco Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Helen R Landicho

FDA Registration(s)

• Registration Number: 2435505
• FEI Number: 1000119795
• Name: POLYMEDCO, INC.
• Owner & Operator: POLYMEDCO, INC.
• Contact Address: 510 FURNACE DOCK RD. --; CORTLANDT MANOR NY 10567 US
• Official Correspondent:
  • HELEN - LANDICHO
  • x-914-7395400-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 510 FURNACE DOCK RD. ; CORTLANDT MANOR, NY 10567 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
GUDID 00816917022925 POLYMEDCO, INC.	Poly stat	2019-04-26
GUDID 00816917021546 POLYMEDCO, INC.	Poly stat	2018-11-08
GUDID 00855574005438 POLYMEDCO, INC.	Poly stat	2018-07-06
GUDID 00855574005421 POLYMEDCO, INC.	Poly stat	2018-07-06
GUDID 00855574005414 POLYMEDCO, INC.	Poly stat	2018-07-06
GUDID 00855574005407 POLYMEDCO, INC.	Poly stat	2018-07-06
GUDID 00855574005391 POLYMEDCO, INC.	Poly stat	2018-07-06
GUDID 00855574005384 POLYMEDCO, INC.	Poly stat	2018-07-06
GUDID 00855574005377 POLYMEDCO, INC.	Poly stat	2018-07-06
GUDID 00855574005360 POLYMEDCO, INC.	PolyTiter	2018-07-06
PMN K983386 | GTY POLYMEDCO, INC.	Poly stat Strep A Strip Test	2018-06-14
JRC POLYMEDCO, INC.	Pipette Tip	2017-08-11
PMN K100130 | MMI POLYMEDCO, INC.	PATHFAST cTnI-II	2017-06-27
PMN K100130 | JIT POLYMEDCO, INC.	PATHFAST cTnI-II	2017-06-27
PMN K083412 | JIT POLYMEDCO, INC.	PATHFAST hsCRP	2017-06-27
PMN K083412 | DCN POLYMEDCO, INC.	PATHFAST hsCRP	2017-06-27
PMN K081360 | JIT POLYMEDCO, INC.	PATHFAST Myo-II	2017-06-27
PMN K081360 | JHX POLYMEDCO, INC.	PATHFAST Myo-II	2017-06-27
PMN K081360 | DDR POLYMEDCO, INC.	PATHFAST Myo-II	2017-06-27
PMN K072288 | GHH POLYMEDCO, INC.	PATHFAST D-Dimer	2017-06-27
PMN K072189 | NBC POLYMEDCO, INC.	PATHFAST NTproBNP	2017-06-27
JJE POLYMEDCO, INC.	PATHFAST Analyzer	2017-06-27
JHE POLYMEDCO, INC.	PATHFAST CK-MB-II	2017-06-27
PMN P130001 | PHP POLYMEDCO, INC.	Epi proColon	2017-05-10
PMN K143325 | KHE POLYMEDCO, INC.	OC-Light S FIT	2015-08-26
PMN K132465 | PSZ POLYMEDCO, INC.	Poly stat FLU A&B Test	2015-02-13
NAH POLYMEDCO, INC.	BTA	2012-08-09
PMN K112408 POLYMEDCO, INC.	POLY-CHEM 90 ISE MODULE	2011-11-04
PMN K110818 POLYMEDCO, INC.	POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS	2011-09-08
PMN K111143 POLYMEDCO, INC.	POLY-CHEM 90 TOTAL BILIRUBIN	2011-09-01
PMN K092330 | OOX POLYMEDCO, INC.	OC-Auto SENSOR DIANA iFOB Test System	2011-01-21
PMN K100550 POLYMEDCO, INC.	POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC	2010-09-28
PMN K090703 POLYMEDCO, INC.	POLY-CHEM 90 GLUCOSE	2009-10-20
JPH POLYMEDCO, INC.	Sediten ESR System	2009-07-10
JPH POLYMEDCO, INC.	Sediplast Tubes	2009-07-10
JPH POLYMEDCO, INC.	Sedimat 15 ESR System	2009-07-10
JPH POLYMEDCO, INC.	Sed-Chek 2 Controls	2009-07-10
PMN K980798 | LYR POLYMEDCO, INC.	PolyStat H. pylori	2009-07-09
PMN K961024 | KTN POLYMEDCO, INC.	PolyStat Mono	2009-07-09
PMN K924061 | JJY POLYMEDCO, INC.	Cancer Antigen Control	2009-07-09
PMN K921206 | JJX POLYMEDCO, INC.	hCG Control	2009-07-09
PMN K041408 | OOX POLYMEDCO, INC.	OC-Auto Micro 80 iFOB Test System	2009-07-09
PMN K041297 | KHE POLYMEDCO, INC.	OC-Light iFOB Test	2009-07-09
PMN K040708 | GTY POLYMEDCO, INC.	Poly stat Strep A Flip Test	2009-07-09
PMN K020439 | JHI POLYMEDCO, INC.	PolyStat hCG	2009-07-09
PMN K012163 | DHN POLYMEDCO, INC.	PolyTiter System	2009-07-09
PMN K974845 | MMW POLYMEDCO, INC.	BTA stat Test Kit	2008-02-01
PMN K971402 | MMW POLYMEDCO, INC.	BTA TRAK Assay	2008-02-01
PMN K053553 POLYMEDCO, INC.	NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL	2006-03-09
PMN K041408 POLYMEDCO, INC.	POLYMEDCO OC AUTO MICRO 80 FOB TEST	2004-10-21
PMN K041297 POLYMEDCO, INC.	POLYMEDCO OC LIGHT FOBT TEST	2004-08-12
PMN K033706 POLYMEDCO, INC.	POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS	2004-02-04
PMN K023654 POLYMEDCO, INC.	GLYCA-DIRECT FRUCTOSAMINE	2003-05-02
PMN K020852 POLYMEDCO, INC.	POLY-CHEM GLUCOSE	2002-07-03
PMN K020532 POLYMEDCO, INC.	POLYMEDCO HBA1C TEST	2002-04-24
PMN K012163 POLYMEDCO, INC.	POLYTITER SYSTEM	2001-08-20
PMN K962049 POLYMEDCO, INC.	C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT	1996-12-18
PMN K955086 POLYMEDCO, INC.	TEST, RHEUMATOID FACTOR	1995-12-20
PMN K924061 POLYMEDCO, INC.	CANCER ANTIGEN CONTROL	1993-02-23
PMN K921206 POLYMEDCO, INC.	HCG CONTROL	1992-04-29
PMN K915325 POLYMEDCO, INC.	TSH CONTROL	1992-03-02

Related Finance Registrations

NCAGE Code	0A9G6	POLYMEDCO, INC.!DBA POLYMEDCO CANCER DIAGNOSTIC!PRODUCTS
CAGE Code	0A9G6	POLYMEDCO, INC. POLYMEDCO CANCER DIAGNOSTIC PRODUCTS
S.A.M. Registration	0A9G6 [24798555]	POLYMEDCO, INC. POLYMEDCO CANCER DIAGNOSTIC PRODUCTS

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020081160647	Genova,Italy -> New York/Newark Area, Newark, New Jersey	LOAD ON 11 PALLETS PLASTIC MEDICAL INSTRUMENT S HS CODE: 3926.9097	442 BOX
2020072036895	Genova,Italy -> New York/Newark Area, Newark, New Jersey	PLASTIC MEDICAL INSTRUMENTS HS CODE: 3926.909	965 BOX
2020052549359	Genova,Italy -> New York/Newark Area, Newark, New Jersey	PLASTIC MEDICAL INSTRUMENTS, BARCODE READERS, ADAPTERS, SPARE PARTS FOR MONITORS HS CODE: 3926.9097 / 84713000 / 84719000 / 85285900	570 BOX
2020032334416	Genova,Italy -> New York/Newark Area, Newark, New Jersey	PLASTIC MEDICAL INSTRUMENTS HS CODE: 3926.909 7 + 7318.1499	1067 PKG
2019123123819	Genova,Italy -> New York/Newark Area, Newark, New Jersey	PLASTIC MEDICAL INSTRUMENTS HS CODE: 3926.909 7 + 8471.3000	687 BOX
2019123155977	Genova,Italy -> New York/Newark Area, Newark, New Jersey	PLASTIC MEDICAL INSTRUMENTS HS CODE: 3926.909	452 BOX
2019111153243	Genova,Italy -> New York/Newark Area, Newark, New Jersey	PLASTIC MEDICAL INSTRUMENTS HS CODE: 3926.909	492 BOX
2019101445395	Genova,Italy -> New York/Newark Area, Newark, New Jersey	LP/POLYMEDCO INC PLASTIC MEDICAL INSTRUMENTS HS CODE: 3926.9097	860 PKG