JJT · Class I · 21 CFR 862.1660

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

Leading manufacturers include Beckman Instruments, Inc., Cala Diagnostics and Bio-Rad.

97
Total
97
Cleared
45d
Avg days
1977
Since
97 devices
25–48 of 97
Cleared Apr 23, 1996
LIQUID CARDIAC MARKER 1,2,3 ASSAYED
K960246
Ciba Corning Diagnostics Corp.
Chemistry · 98d
Cleared Sep 21, 1995
ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE
K950803
Isolab, Inc.
Chemistry · 212d
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 Jan 24, 1995
CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL
K946145
Clinical Controls, Inc.
Chemistry · 39d
Cleared Jan 24, 1995
CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION
K946146
Clinical Controls, Inc.
Chemistry · 39d
Cleared Nov 04, 1994
CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3,
K944923
Clinical Controls, Inc.
Chemistry · 29d
Cleared Oct 31, 1994
CARDIOCHEX CKMB MASS MEASUREMENT CONTROL
K944246
Cala Diagnostics
Chemistry · 61d
Cleared Oct 31, 1994
CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL
K944247
Cala Diagnostics
Chemistry · 61d
Cleared Oct 27, 1994
CARDIOCHEX
K944243
Cala Diagnostics
Chemistry · 57d
Cleared Oct 04, 1994
HICHEM ENZYME VERIFIER KIT
K943684
Hi Chem, Inc.
Chemistry · 67d
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 Apr 13, 1993
CKMB ISOENZYME CONTROL-LEVEL 1,2.3
K930873
Cala Diagnostics
Chemistry · 53d
Cleared Apr 13, 1993
CKMB CONTROL - LEVEL 1,2,3
K930875
Cala Diagnostics
Chemistry · 53d
Cleared Dec 17, 1992
LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3
K925151
Bio-Rad
Chemistry · 65d
Cleared Feb 22, 1991
CK-MB IMMUNOASSAY CONTROL
K905623
Seradyn, Inc.
Chemistry · 70d
Cleared Aug 23, 1990
LIQUICHEK CK/LD ISOENZYME CONTROL
K903430
Bio-Rad
Chemistry · 23d
Cleared Jun 28, 1990
HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235)
K902321
Hichem Diagnostics
Chemistry · 36d
Cleared Mar 01, 1990
CLP CK/LD ISOENZYME/IMMUNO CONTROL
K896465
Creative Laboratory Products, Inc.
Chemistry · 108d
Cleared Oct 16, 1989
CLP CK/LD ISOENZYME CONTROL
K894554
Creative Laboratory Products, Inc.
Chemistry · 88d
Cleared Aug 28, 1989
CK-MB/LD-1 CONTROL SYSTEM
K894207
Boehringer Mannheim Corp.
Chemistry · 70d
Cleared Sep 19, 1988
ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY
K883395
Quantimetrix Medical Industries
Chemistry · 39d
Cleared Aug 29, 1988
DADE(R) CK-MB IMMUNOASSAY CONTROL
K882795
Baxter Healthcare Corp
Chemistry · 54d