JFH · Class II · 21 CFR 862.1020

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

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

45
Total
45
Cleared
65d
Avg days
1979
Since

FDA 510(k) Cleared Acid Phosphatase (prostatic), Tartrate Inhibited Devices (Product Code JFH)

45 devices
1–24 of 45
Cleared Feb 23, 2000
IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6
K000257
Diagnostic Products Corp.
Immunology · 27d
Cleared Jan 27, 1994
IMMULITE PAP
K931701
Diagnostic Products Corp.
Chemistry · 296d
Cleared Jan 13, 1993
IMX PAP
K925377
Abbott Laboratories
Chemistry · 82d
Cleared Sep 21, 1990
MILENIA PAP IRMA CATALOG #: MKPA1, X
K902937
Diagnostic Products Corp.
Chemistry · 80d
Cleared Jun 28, 1990
COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2
K901933
Diagnostic Products Corp.
Chemistry · 59d
Cleared Oct 31, 1989
IRMA-COUNT(TM) PAP, (RKPA1, RKPA2)
K895723
Diagnostic Products Corp.
Chemistry · 36d
Cleared Aug 04, 1989
PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI
K893508
Baxter Healthcare Corp
Pathology · 91d
Cleared Dec 01, 1987
ABBOTT PAP-EIA
K873903
Abbott Laboratories
Chemistry · 68d
Cleared Sep 04, 1985
PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY
K852845
Diagnostic Products Corp.
Chemistry · 61d
Cleared May 16, 1983
CORDIA PAP
K831105
Cordis Corp.
Immunology · 41d
Cleared Jan 19, 1982
ABBOTT PAP-EIA
K812925
Abbott Laboratories
Chemistry · 92d
Cleared May 27, 1981
PROSTATIC ACID PHOSPHATASE RADIOIMM. KIT
K811274
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 20d
Cleared Jan 02, 1981
RIAPHASE (125I) PROST. ACID PHOSPH. KIT
K803043
Beckman Instruments, Inc.
Chemistry · 32d

About Product Code JFH - Regulatory Context