JFH · Class II · 21 CFR 862.1020

FDA Product Code JFH: Acid Phosphatase (prostatic), Tartrate Inhibited

Leading manufacturers include Diagnostic Products Corp., Hybritech, Inc. and Abbott Laboratories.

45
Total
45
Cleared
65d
Avg days
1979
Since
45 devices
25–45 of 45
Cleared Dec 17, 1981
RIAGEN PAP RIA
K813261
Biogenex Laboratories
Chemistry · 27d
Cleared Sep 01, 1981
TANDEM PAP KIT - (PARTS I & II)
K811959
Hybritech, Inc.
Chemistry · 54d
Cleared Aug 13, 1981
NEIA PAP ENZYMEIMMUNOASSAY
K811757
New England Immunology Assoc.
Immunology · 52d
Cleared May 27, 1981
PROSTATIC ACID PHOSPHATASE RADIOIMM. KIT
K811274
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 20d
Cleared May 15, 1981
PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT
K811169
Amersham Corp.
Chemistry · 17d
Cleared Feb 26, 1981
ESKACHEM PAP REAGENT
K803234
Smithkline Diagnostics, Inc.
Chemistry · 66d
Cleared Feb 10, 1981
LEECO P.A.P. - QUANT DIAGNOSTIC KIT
K810232
Leeco Diagnostics, Inc.
Chemistry · 14d
Cleared Jan 28, 1981
NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS-
K802886
Nuclear Diagnostics, Inc.
Chemistry · 72d
Cleared Jan 02, 1981
RIAPHASE (125I) PROST. ACID PHOSPH. KIT
K803043
Beckman Instruments, Inc.
Chemistry · 32d
Cleared Nov 12, 1980
CBC PAP TEST KIT
K802153
Calbiochem-Behring Corp.
Chemistry · 65d
Cleared Sep 26, 1980
NORDICLAB PROSTATIC ACID PHOSPHATASE RIA
K801988
Nordiclab Intl.
Chemistry · 38d
Cleared Jan 16, 1980
LEECO P.A.P. QUANT. DIAGNOSTIC KIT
K792652
Leeco Diagnostics, Inc.
Chemistry · 26d
Cleared Dec 13, 1979
S.F.-P.A.P. TEST COUNTER IMMUNOELECTRO
K792059
S.F. Biologicals, Inc.
Chemistry · 59d
Cleared Dec 07, 1979
ELVI ACID & PROSTATIC PHOSPHATASE
K792405
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 04, 1979
PROSTATIC ACID RADIOIMMUNOASSAY TEST
K791497
Clinical Assays, Inc.
Chemistry · 123d
Cleared Nov 15, 1979
PAP RIA KIT
K791735
Nuclear Medical Systems, Inc.
Chemistry · 77d
Cleared Oct 30, 1979
PAP-CHECK RIA KIT
K792043
Serono Laboratories, Inc.
Chemistry · 18d
Cleared May 25, 1979
RIA KIT, PROSTATIC ACID
K790580
Monitor Science Corp.
Chemistry · 59d
Cleared May 07, 1979
PAP RIA KIT
K790317
Yang Laboratories, Inc.
Chemistry · 81d
Cleared May 07, 1979
RIA KIT, QUANTITATION OF PROSTATIC ACID
K790817
New England Nuclear
Chemistry · 10d
Cleared Apr 17, 1979
P.A.P. TEST KIT, RIA-ZYME
K790040
Mallinckrodt Critical Care
Chemistry · 99d