JHY · Class II · 21 CFR 862.1215

FDA Product Code JHY: Colorimetric Method, Cpk Or Isoenzymes

Leading manufacturers include Hybritech, Inc., Abbott Laboratories and Roche Diagnostics.

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 Sep 18, 2015
Dimension Vista MMB Assay
K143720
Siemens Healthcare Diagnostics
Chemistry · 263d
Cleared May 13, 2014
EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL
K130080
Medica Corporation
Chemistry · 484d
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 Jun 04, 2007
OLYMPUS CK-MB REAGENT
K070835
Olympus Life & Material Science Europa GmbH (Irish
Chemistry · 69d
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 Feb 14, 1997
MMB METHOD
K970343
Dade Chemistry Systems, Inc.
Chemistry · 16d
Cleared Jun 18, 1996
CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO
K961412
Bayer Corp.
Toxicology · 67d
Cleared May 02, 1995
AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK
K951638
Organon Teknika Corp.
Chemistry · 22d
Cleared Jun 15, 1993
IMX(R) STAT CK-MB
K931172
Abbott Laboratories
Chemistry · 99d
Cleared Oct 15, 1992
OPUS(R) CK-MB
K924429
Pb Diagnostic Systems, Inc.
Toxicology · 44d
Cleared Aug 20, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.
K922700
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 77d
Cleared Jun 09, 1992
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
K921763
Hybritech, Inc.
Chemistry · 56d
Cleared Jul 17, 1991
AMERLITE CK-MB ASSAY
K912766
Amersham Corp.
Chemistry · 23d
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 Aug 15, 1989
TARGET(TM) CK-MB
K890295
V-Tech, Inc.
Chemistry · 208d
Cleared Feb 23, 1989
CREATINE KINASE MB ENZYME IMMUNOASSAY KIT
K884550
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 115d
Cleared Dec 02, 1988
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
K884085
Hybritech, Inc.
Chemistry · 66d
Cleared Aug 08, 1988
IMX CKMB
K883013
Abbott Laboratories
Chemistry · 20d
Cleared Jun 01, 1988
IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225
K881351
Intl. Immunoassay Laboratories, Inc.
Chemistry · 63d
Cleared Feb 24, 1988
KODAK EKTACHEM DT SLIDES (CKMB)
K875192
Eastman Kodak Company
Chemistry · 69d

About Product Code JHY - Regulatory Context