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 Cala Diagnostics.

97
Total
97
Cleared
45d
Avg days
1977
Since
97 devices
49–72 of 97
Cleared Mar 24, 1988
QUANTIMETRIX SERUM ENZYME CONTROL
K880701
Quantimetrix Corp.
Chemistry · 31d
Cleared Feb 18, 1988
MULTI-ENZYME LINEARITY SOLUTION
K880266
Verichem Laboratories, Inc.
Chemistry · 27d
Cleared Feb 02, 1988
QUANTIMETRIX TOTAL CREATINE KINASE CONTROL
K874302
Quantimetrix Medical Industries
Chemistry · 105d
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 Apr 13, 1987
U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL
K870737
U. S. Diagnostics, Inc.
Chemistry · 47d
Cleared Apr 13, 1987
U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL
K870738
U. S. Diagnostics, Inc.
Chemistry · 47d
Cleared Jun 13, 1986
DOCUMENT ENZYME LINEARITY TEST SETS
K861506
Casco Standards
Chemistry · 51d
Cleared May 23, 1986
EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95
K861512
Em Diagnostic Systems, Inc.
Chemistry · 30d
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 17, 1986
CANTROL CK/MB CONTROL
K855006
Canyon Diagnostics, 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 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/
K850907
Cala Diagnostics
Chemistry · 112d
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