Acid Phosphatase (Prostatic), Tartrate Inhibited

FDA product code JFH · 45 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1020
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1979-04-17 – 2000-02-23

JFH 2000-02-23

IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6

Applicant Diagnostic Products Corp.

K number K000257

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JFH 1998-09-15

UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE

Applicant United Biotech, Inc.

K number K981573

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JFH 1997-04-23

PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT

Applicant Wano-Tech Corp.

K number K964756

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JFH 1994-01-27

IMMULITE PAP

Applicant Diagnostic Products Corp.

K number K931701

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JFH 1993-01-13

IMX PAP

Applicant Abbott Laboratories

K number K925377

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JFH 1992-07-30

HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO

Applicant Hybritech, Inc.

K number K921745

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JFH 1990-09-21

MILENIA PAP IRMA CATALOG #: MKPA1, X

Applicant Diagnostic Products Corp.

K number K902937

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JFH 1990-06-28

COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2

Applicant Diagnostic Products Corp.

K number K901933

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JFH 1989-10-31

IRMA-COUNT(TM) PAP, (RKPA1, RKPA2)

Applicant Diagnostic Products Corp.

K number K895723

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JFH 1989-08-04

PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI

Applicant Baxter Healthcare Corp

K number K893508

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JFH 1989-01-30

TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC)

Applicant Technicon Instruments Corp.

K number K884748

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JFH 1987-12-01

ABBOTT PAP-EIA

Applicant Abbott Laboratories

K number K873903

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JFH 1987-01-05

TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY

Applicant Hybritech, Inc.

K number K864945

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JFH 1986-12-16

NAPHTHYL PHOSPHATE, ACID PHOSPHATASE

Applicant Pointe Scientific, Inc.,

K number K863832

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JFH 1985-09-04

PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY

Applicant Diagnostic Products Corp.

K number K852845

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JFH 1985-06-25

TANDEM E PAP

Applicant Hybritech, Inc.

K number K851950

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JFH 1985-04-29

DSL PAP RIA -DSL#3100

Applicant Diagnostic Systems Laboratories, Inc.

K number K844679

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JFH 1985-02-07

EPICHROME PAP

Applicant Cetus Corp.

K number K844968

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JFH 1984-09-04

VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC

Applicant Ventrex Laboratories, Inc.

K number K843230

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JFH 1983-08-24

ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO

Applicant Ortho Diagnostic Systems, Inc.

K number K831670

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JFH 1983-05-16

CORDIA PAP

Applicant Cordis Corp.

K number K831105

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JFH 1982-09-02

DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI

Applicant Nuclear Medical Laboratories, Inc.

K number K822298

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JFH 1982-04-14

FLUOROGEN PAP FIA

Applicant Biogenex Laboratories

K number K820724

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JFH 1982-01-19

ABBOTT PAP-EIA

Applicant Abbott Laboratories

K number K812925

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JFH 1981-12-17

RIAGEN PAP RIA

Applicant Biogenex Laboratories

K number K813261

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JFH 1981-09-01

TANDEM PAP KIT - (PARTS I & II)

Applicant Hybritech, Inc.

K number K811959

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JFH 1981-08-13

NEIA PAP ENZYMEIMMUNOASSAY

Applicant New England Immunology Assoc.

K number K811757

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JFH 1981-05-27

PROSTATIC ACID PHOSPHATASE RADIOIMM. KIT

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K811274

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JFH 1981-05-15

PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT

Applicant Amersham Corp.

K number K811169

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JFH 1981-02-26

ESKACHEM PAP REAGENT

Applicant Smithkline Diagnostics, Inc.

K number K803234

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JFH 1981-02-10

LEECO P.A.P. - QUANT DIAGNOSTIC KIT

Applicant Leeco Diagnostics, Inc.

K number K810232

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JFH 1981-01-28

NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS-

Applicant Nuclear Diagnostics, Inc.

K number K802886

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JFH 1981-01-02

RIAPHASE (125I) PROST. ACID PHOSPH. KIT

Applicant Beckman Instruments, Inc.

K number K803043

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JFH 1980-11-12

CBC PAP TEST KIT

Applicant Calbiochem-Behring Corp.

K number K802153

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JFH 1980-09-26

NORDICLAB PROSTATIC ACID PHOSPHATASE RIA

Applicant Nordiclab Intl.

K number K801988

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JFH 1980-01-16

LEECO P.A.P. QUANT. DIAGNOSTIC KIT

Applicant Leeco Diagnostics, Inc.

K number K792652

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JFH 1979-12-13

S.F.-P.A.P. TEST COUNTER IMMUNOELECTRO

Applicant S.F. Biologicals, Inc.

K number K792059

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JFH 1979-12-07

ELVI ACID & PROSTATIC PHOSPHATASE

Applicant Volu Sol Medical Industries

K number K792405

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JFH 1979-12-04

PROSTATIC ACID RADIOIMMUNOASSAY TEST

Applicant Clinical Assays, Inc.

K number K791497

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JFH 1979-11-15

PAP RIA KIT

Applicant Nuclear Medical Systems, Inc.

K number K791735

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JFH 1979-10-30

PAP-CHECK RIA KIT

Applicant Serono Laboratories, Inc.

K number K792043

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JFH 1979-05-25

RIA KIT, PROSTATIC ACID

Applicant Monitor Science Corp.

K number K790580

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JFH 1979-05-07

RIA KIT, QUANTITATION OF PROSTATIC ACID

Applicant New England Nuclear

K number K790817

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JFH 1979-05-07

PAP RIA KIT

Applicant Yang Laboratories, Inc.

K number K790317

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JFH 1979-04-17

P.A.P. TEST KIT, RIA-ZYME

Applicant Mallinckrodt Critical Care

K number K790040

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