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510(k) K921745

Device
HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO
Applicant
HYBRITECH, INC.
510(k) number
K921745
Product code
JFH  
Decision
Substantially Equivalent (SESE)
Decision date
1992-07-30
Date received
1992-04-13
Regulation
862.1020
Classification name
Acid Phosphatase (prostatic), Tartrate Inhibited
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOANNE MARTINIS
Address
P.O. Box 269006 San Diego CA US 92196 92196

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JFH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K000257IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6Diagnostic Products Corp.2000-02-23
K981573UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVEUnited Biotech, Inc.1998-09-15
K964756PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KITWano-Tech Corp.1997-04-23
K931701IMMULITE PAPDiagnostic Products Corp.1994-01-27
K925377IMX PAPAbbott Laboratories1993-01-13
K902937MILENIA PAP IRMA CATALOG #: MKPA1, XDiagnostic Products Corp.1990-09-21
K901933COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2Diagnostic Products Corp.1990-06-28
K895723IRMA-COUNT(TM) PAP, (RKPA1, RKPA2)Diagnostic Products Corp.1989-10-31
K893508PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTIBaxter Healthcare Corp1989-08-04
K884748TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC)Technicon Instruments Corp.1989-01-30
K873903ABBOTT PAP-EIAAbbott Laboratories1987-12-01
K864945TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAYHybritech, Inc.1987-01-05
K863832NAPHTHYL PHOSPHATE, ACID PHOSPHATASEPointe Scientific, Inc.,1986-12-16
K852845PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAYDiagnostic Products Corp.1985-09-04
K851950TANDEM E PAPHybritech, Inc.1985-06-25

Legacy Summary#

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FDA Review#

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