FDA Product Code JHT: Chromatographic Separation, Cpk Isoenzymes
Leading manufacturers include Helena Laboratories, Coulter Electronics, Inc. and Diagnostic Chemicals, Ltd. (Usa).
21
Total
21
Cleared
71d
Avg days
1976
Since
FDA 510(k) Cleared Chromatographic Separation, Cpk Isoenzymes Devices (Product Code JHT)
21 devices
Cleared
May 28, 1999
MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI
Princeton BioMeditech Corp.
Chemistry
52d
Cleared
Apr 12, 1993
CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305
Helena Laboratories
Chemistry
76d
Cleared
Dec 13, 1990
DSL CK-MB (DSL #3200)
Diagnostic Systems Laboratories, Inc.
Toxicology
56d
Cleared
Dec 13, 1990
COULTER CK-MB ISOENZYME REAGENT
Coulter Electronics, Inc.
Chemistry
45d
Cleared
May 15, 1990
MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB
Intl. Immunoassay Laboratories, Inc.
Chemistry
48d
Cleared
Feb 16, 1990
REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083
Helena Laboratories
Chemistry
114d
Cleared
Nov 10, 1988
CREATINE KINASE (CK) ISOENZYME MB
Data Medical Associates, Inc.
Chemistry
237d
Cleared
Jan 21, 1988
SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM
Diagnostic Chemicals, Ltd. (Usa)
Chemistry
99d
Cleared
Sep 16, 1987
COULTER DART CK-MB ISOENZYME REAGENT SYSTEM
Coulter Electronics, Inc.
Chemistry
112d
Cleared
Jan 07, 1983
CK-ISOZYME U.V. REAGENT SET
Gelman Sciences, Inc.
Chemistry
38d
Cleared
Nov 01, 1982
TITAN GEL CPK ISOENZYME SYSTEM
Helena Laboratories
Chemistry
105d
Cleared
Oct 01, 1979
CPK CLINI GEL KIT
Clinical Sciences, Inc.
Chemistry
14d
Cleared
Apr 04, 1979
CPK-CS
Hoffmann-La Roche, Inc.
Chemistry
40d
Cleared
Aug 22, 1977
CK-MB
Boehringer Mannheim Corp.
Chemistry
17d
Cleared
Sep 15, 1976
CPK - ISOENZYMES
Harleco
Chemistry
93d