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Panels › Clinical Chemistry › Product code JFH · Class 2

Acid Phosphatase (Prostatic), Tartrate Inhibited

Regulation 862.1020

0510(k)s in 12 months (45 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
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Top companies in JFH

Company510(k)sRecalls
Diagnostic Products Corp.60
Hybritech, Inc.40
Abbott Laboratories30
Biogenex Laboratories20
Leeco Diagnostics, Inc.20
Amersham Corp.10
Baxter Healthcare Corp10
Bd Becton Dickinson Vacutainer Systems Preanalytic10
Beckman Instruments, Inc.10
Calbiochem-Behring Corp.10
Decided510(k)Device and applicantCode
Feb 23, 2000K000257IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6
Diagnostic Products Corp.
JFH
Sep 15, 1998K981573UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE
United Biotech, Inc.
JFH
Apr 23, 1997K964756PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT
Wano-Tech Corp.
JFH
Jan 27, 1994K931701IMMULITE PAP
Diagnostic Products Corp.
JFH
Jan 13, 1993K925377IMX PAP
Abbott Laboratories
JFH
Jul 30, 1992K921745HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO
Hybritech, Inc.
JFH
Sep 21, 1990K902937MILENIA PAP IRMA CATALOG #: MKPA1, X
Diagnostic Products Corp.
JFH
Jun 28, 1990K901933COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2
Diagnostic Products Corp.
JFH
Oct 31, 1989K895723IRMA-COUNT(TM) PAP, (RKPA1, RKPA2)
Diagnostic Products Corp.
JFH
Aug 4, 1989K893508PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI
Baxter Healthcare Corp
JFH
Jan 30, 1989K884748TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC)
Technicon Instruments Corp.
JFH
Dec 1, 1987K873903ABBOTT PAP-EIA
Abbott Laboratories
JFH
Jan 5, 1987K864945TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY
Hybritech, Inc.
JFH
Dec 16, 1986K863832NAPHTHYL PHOSPHATE, ACID PHOSPHATASE
Pointe Scientific, Inc.,
JFH
Sep 4, 1985K852845PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY
Diagnostic Products Corp.
JFH
Jun 25, 1985K851950TANDEM E PAP
Hybritech, Inc.
JFH
Apr 29, 1985K844679DSL PAP RIA -DSL#3100
Diagnostic Systems Laboratories, Inc.
JFH
Feb 7, 1985K844968EPICHROME PAP
Cetus Corp.
JFH
Sep 4, 1984K843230VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC
Ventrex Laboratories, Inc.
JFH
Aug 24, 1983K831670ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO
Ortho Diagnostic Systems, Inc.
JFH
May 16, 1983K831105CORDIA PAP
Cordis Corp.
JFH
Sep 2, 1982K822298DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI
Nuclear Medical Laboratories, Inc.
JFH
Apr 14, 1982K820724FLUOROGEN PAP FIA
Biogenex Laboratories
JFH
Jan 19, 1982K812925ABBOTT PAP-EIA
Abbott Laboratories
JFH
Dec 17, 1981K813261RIAGEN PAP RIA
Biogenex Laboratories
JFH
Sep 1, 1981K811959TANDEM PAP KIT - (PARTS I & II)
Hybritech, Inc.
JFH
Aug 13, 1981K811757NEIA PAP ENZYMEIMMUNOASSAY
New England Immunology Assoc.
JFH
May 27, 1981K811274PROSTATIC ACID PHOSPHATASE RADIOIMM. KIT
Bd Becton Dickinson Vacutainer Systems Preanalytic
JFH
May 15, 1981K811169PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT
Amersham Corp.
JFH
Feb 26, 1981K803234ESKACHEM PAP REAGENT
Smithkline Diagnostics, Inc.
JFH
Feb 10, 1981K810232LEECO P.A.P. - QUANT DIAGNOSTIC KIT
Leeco Diagnostics, Inc.
JFH
Jan 28, 1981K802886NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS-
Nuclear Diagnostics, Inc.
JFH
Jan 2, 1981K803043RIAPHASE (125I) PROST. ACID PHOSPH. KIT
Beckman Instruments, Inc.
JFH
Nov 12, 1980K802153CBC PAP TEST KIT
Calbiochem-Behring Corp.
JFH
Sep 26, 1980K801988NORDICLAB PROSTATIC ACID PHOSPHATASE RIA
Nordiclab Intl.
JFH
Jan 16, 1980K792652LEECO P.A.P. QUANT. DIAGNOSTIC KIT
Leeco Diagnostics, Inc.
JFH
Dec 13, 1979K792059S.F.-P.A.P. TEST COUNTER IMMUNOELECTRO
S.F. Biologicals, Inc.
JFH
Dec 7, 1979K792405ELVI ACID & PROSTATIC PHOSPHATASE
Volu Sol Medical Industries
JFH
Dec 4, 1979K791497PROSTATIC ACID RADIOIMMUNOASSAY TEST
Clinical Assays, Inc.
JFH
Nov 15, 1979K791735PAP RIA KIT
Nuclear Medical Systems, Inc.
JFH
Oct 30, 1979K792043PAP-CHECK RIA KIT
Serono Laboratories, Inc.
JFH
May 25, 1979K790580RIA KIT, PROSTATIC ACID
Monitor Science Corp.
JFH
May 7, 1979K790817RIA KIT, QUANTITATION OF PROSTATIC ACID
New England Nuclear
JFH
May 7, 1979K790317PAP RIA KIT
Yang Laboratories, Inc.
JFH
Apr 17, 1979K790040P.A.P. TEST KIT, RIA-ZYME
Mallinckrodt Critical Care
JFH

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