JJT · Class I · 21 CFR 862.1660

FDA Product Code JJT: Enzyme Controls (assayed And Unassayed)

Leading manufacturers include Beckman Instruments, Inc., Bio-Rad and Helena Laboratories.

97
Total
97
Cleared
45d
Avg days
1977
Since
97 devices
49–72 of 97
Cleared Apr 30, 1986
ISOTRAK AMYLASE ISOENZYME CONTROL SET
K861329
Behring Diagnostics, Inc.
Chemistry · 21d
Cleared Apr 07, 1986
EMDS ENZYME VERIFIER, LEVELS I & II
K860764
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jan 13, 1986
V-TREND OC CPK
K854973
V-Tech, Inc.
Chemistry · 33d
Cleared Aug 23, 1985
DELTA TROL I & II
K853373
Electro-Nucleonics Laboratories, Inc.
Chemistry · 11d
Cleared Jun 25, 1985
CK/LD ISOENZYMES CONTROLS(HUMAN)
K851520
Seragen Diagnostics, Inc.
Chemistry · 71d
Cleared Mar 05, 1985
ISOCONTROL SERUM CK-MB
K850213
Sclavo, Inc.
Chemistry · 49d
Cleared Feb 07, 1985
ISOCONTROL SERUM LD-
K850211
Sclavo, Inc.
Chemistry · 23d
Cleared Sep 13, 1984
ID ZINE LD ISOENZYME CONTROL ABNORM
K843265
Beckman Instruments, Inc.
Microbiology · 24d
Cleared Sep 13, 1984
ID ZONE NORMAL LD ISOENZYME CONTROL
K843266
Beckman Instruments, Inc.
Chemistry · 24d
Cleared Apr 13, 1984
CK/MB IMMUNO-ISOENZYME CONTROL SERUM
K840793
Seragen Diagnostics, Inc.
Chemistry · 50d
Cleared Nov 10, 1982
ID-ZONE LD ISOENZYME CONTROL
K822984
Beckman Instruments, Inc.
Chemistry · 29d
Cleared Sep 30, 1982
QUANTAPHOS ACID PHOSPHATOSE CONT. SERUM
K822646
Beckman Instruments, Inc.
Chemistry · 28d
Cleared Jul 22, 1982
TITAN GEL CPK/LDH ISOENZYME CONTROL
K821981
Helena Laboratories
Chemistry · 16d
Cleared May 14, 1982
TARGET ISOCHECK CONTROL SERUM
K821183
Smithkline Diagnostics, Inc.
Chemistry · 17d
Cleared Mar 04, 1982
AALTO LDH ISOENZYME CONTROL SERUM
K820360
Aalto Scientific, Ltd.
Chemistry · 23d
Cleared Oct 02, 1981
EMBRITROL CK-MB CONTROLS
K812671
Intl. Immunoassay Laboratories, Inc.
Chemistry · 11d
Cleared Mar 31, 1981
QUALITROL #65057
K810725
Harleco
Immunology · 14d
Cleared Jan 16, 1981
DUPONT 'ACA' CREATINE KINASE VERIFIERS
K803305
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 17d
Cleared Apr 10, 1980
CK ISOENZYME ELECTROPHORESIS CONTROL-I.D
K800604
Beckman Instruments, Inc.
Chemistry · 24d
Cleared Oct 01, 1979
QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN)
K791723
Organon, Inc.
Chemistry · 32d
Cleared Aug 16, 1979
CPK ISOENZYME CONTROL
K791299
Electrophoresis Corp. of America
Chemistry · 31d
Cleared Aug 16, 1979
LDH ISOENZYME CONTROL
K791300
Electrophoresis Corp. of America
Chemistry · 31d
Cleared Jul 17, 1979
P.A.P. RIA CONTROL SERUM PACK
K790985
Mallinckrodt Critical Care
Chemistry · 53d
Cleared Aug 14, 1978
DELTA TEST AMYLASE/LIPASE CONTS. I,II
K781100
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 42d