JHY · Class II · 21 CFR 862.1215

FDA Product Code JHY: Colorimetric Method, Cpk Or Isoenzymes

Leading manufacturers include Roche Diagnostics, Abbott Laboratories and Roche Diagnostic Systems, Inc..

40
Total
40
Cleared
72d
Avg days
1976
Since

FDA 510(k) Cleared Colorimetric Method, Cpk Or Isoenzymes Devices (Product Code JHY)

40 devices
1–24 of 40
Cleared May 08, 2014
ELECSYS CK-MB STAT IMMUNOASSAY
K140404
Roche Diagnostics
Chemistry · 79d
Cleared Oct 18, 2013
ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
K132571
Roche Diagnostics
Chemistry · 64d
Cleared Oct 11, 2002
SPIFE CK KIT, MODEL 3332, 3333
K022757
Helena Laboratories
Chemistry · 52d
Cleared Aug 29, 2002
MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
K022654
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Dec 17, 1997
ELECSYS CK-MB STAT
K974421
Boehringer Mannheim Corp.
Chemistry · 23d
Cleared Jun 15, 1993
IMX(R) STAT CK-MB
K931172
Abbott Laboratories
Chemistry · 99d
Cleared Aug 20, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.
K922700
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 77d
Cleared Feb 16, 1990
COBAS READY CK REAGENT
K896240
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Dec 01, 1989
ISOSCREEN-CK CONFIRMATORY KIT
K895870
Roche Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Feb 23, 1989
CREATINE KINASE MB ENZYME IMMUNOASSAY KIT
K884550
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 115d
Cleared Aug 08, 1988
IMX CKMB
K883013
Abbott Laboratories
Chemistry · 20d
Cleared Feb 24, 1988
KODAK EKTACHEM DT SLIDES (CKMB)
K875192
Eastman Kodak Company
Chemistry · 69d
Cleared Dec 21, 1976
CPK1SOENZYMES DETERMINATION PRO. #715-EP
K761212
Sigma Chemical Co.
Chemistry · 14d

About Product Code JHY - Regulatory Context