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

FDA 510(k) Cleared Enzyme Controls (assayed And Unassayed) Devices (Product Code JJT)

97 devices
1–24 of 97
Cleared May 24, 2002
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
K021498
Bio-Rad
Chemistry · 15d
Cleared Sep 06, 2001
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
K012656
Bio-Rad
Chemistry · 24d
Cleared Feb 02, 1999
QUANTEX ASO-CRP-RP CONTROL II
K984437
Instrumentation Laboratory CO
Chemistry · 50d
Cleared Feb 25, 1998
LIQUICHEK CARDIAC MARKERS CONTROL LT
K980556
Bio-Rad
Chemistry · 12d
Cleared May 27, 1997
QUANTEX ASO-CRP-RF CONTROL
K971777
Instrumentation Laboratory CO
Chemistry · 13d
Cleared Jun 11, 1996
LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688)
K961828
Bio-Rad
Chemistry · 29d
Cleared Apr 20, 1995
QUANTITATE ENZYME VERIFIER SET
K951293
Beckman Instruments, Inc.
Chemistry · 29d
Cleared Mar 30, 1995
CARDIO REP LD CONTROL - CAT NO. 3325
K950801
Helena Laboratories
Chemistry · 37d
Cleared Oct 28, 1993
CARDIO REP RECOMBINANT CK ABNORMAL CONTROL
K932442
Helena Laboratories
Chemistry · 161d
Cleared Jul 06, 1993
ROCHE CARDIOTROL-CK
K930889
Roche Diagnostic Systems, Inc.
Chemistry · 134d
Cleared Dec 17, 1992
LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3
K925151
Bio-Rad
Chemistry · 65d
Cleared Aug 23, 1990
LIQUICHEK CK/LD ISOENZYME CONTROL
K903430
Bio-Rad
Chemistry · 23d
Cleared Aug 28, 1989
CK-MB/LD-1 CONTROL SYSTEM
K894207
Boehringer Mannheim Corp.
Chemistry · 70d
Cleared Aug 29, 1988
DADE(R) CK-MB IMMUNOASSAY CONTROL
K882795
Baxter Healthcare Corp
Chemistry · 54d
Cleared Nov 04, 1987
TITAN GEL REP CPK/LDH ISOENZYME CONTROL
K874141
Helena Laboratories
Chemistry · 22d
Cleared Sep 14, 1987
VIRON(TM)
K872646
bioMerieux, Inc.
Chemistry · 70d
Cleared May 23, 1986
EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95
K861512
Em Diagnostic Systems, Inc.
Chemistry · 30d
Cleared Apr 07, 1986
EMDS ENZYME VERIFIER, LEVELS I & II
K860764
Em Diagnostic Systems, Inc.
Chemistry · 35d
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 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 Jan 16, 1981
DUPONT 'ACA' CREATINE KINASE VERIFIERS
K803305
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 17d

About Product Code JJT - Regulatory Context