Product code JHY

Device name: Colorimetric Method, Cpk Or Isoenzymes
Medical specialty: Clinical Chemistry
Device class: 2
Regulation number: 862.1215
Review panel: CH
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K143720	Dimension Vista MMB Assay	Siemens Healthcare Diagnostics	2015-09-18
K130080	EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL	Medica Corporation	2014-05-13
K140404	ELECSYS CK-MB STAT IMMUNOASSAY	Roche Diagnostics	2014-05-08
K132571	ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY	Roche Diagnostics	2013-10-18
K070835	OLYMPUS CK-MB REAGENT	Olympus Life & Material Science Europa GmbH (Irish	2007-06-04
K022757	SPIFE CK KIT, MODEL 3332, 3333	Helena Laboratories	2002-10-11
K022654	MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB	Roche Diagnostics Corp.	2002-08-29
K974421	ELECSYS CK-MB STAT	Boehringer Mannheim Corp.	1997-12-17
K970343	MMB METHOD	Dade Chemistry Systems, Inc.	1997-02-14
K961412	CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO	Bayer Corp.	1996-06-18
K951638	AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK	Organon Teknika Corp.	1995-05-02
K931172	IMX(R) STAT CK-MB	Abbott Laboratories	1993-06-15
K924429	OPUS(R) CK-MB	Pb Diagnostic Systems, Inc.	1992-10-15
K922700	DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.	E.I. Dupont DE Nemours & Co., Inc.	1992-08-20
K921763	TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY	Hybritech, Inc.	1992-06-09
K912766	AMERLITE CK-MB ASSAY	Amersham Corp.	1991-07-17
K896240	COBAS READY CK REAGENT	Roche Diagnostic Systems, Inc.	1990-02-16
K895870	ISOSCREEN-CK CONFIRMATORY KIT	Roche Diagnostic Systems, Inc.	1989-12-01
K890295	TARGET(TM) CK-MB	V-Tech, Inc.	1989-08-15
K884550	CREATINE KINASE MB ENZYME IMMUNOASSAY KIT	Bd Becton Dickinson Vacutainer Systems Preanalytic	1989-02-23
K884085	TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY	Hybritech, Inc.	1988-12-02
K883013	IMX CKMB	Abbott Laboratories	1988-08-08
K881351	IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225	Intl. Immunoassay Laboratories, Inc.	1988-06-01
K875192	KODAK EKTACHEM DT SLIDES (CKMB)	Eastman Kodak Company	1988-02-24
K880178	CREATINE KINASE (COLORIMETRIC METHOD)	Tech-Co, Inc.	1988-02-18
K874545	IMACK-MB TEST PROCEDURE (MODIFICATION)	Intl. Immunoassay Laboratories, Inc.	1987-12-18
K872063	TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II	Hybritech, Inc.	1987-06-19
K871677	CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS	Catachem, Inc.	1987-05-12
K860663	AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT	Amresco, Inc.	1986-04-11
K845024	BAKER CKMB REAGENT SET	Hybritech, Inc.	1985-01-18

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00816870022345	CK-MB AccuLite CLIA Test System - 192 Wells	MONOBIND, INC.	2019-02-11
00816870022338	Monobind AccuLite CKMB CLIA Kit - 96 Wells	MONOBIND, INC.	2019-02-11
00816870020662	CK-MB AccuBind ELISA Test System - 192 Wells	MONOBIND, INC.	2019-02-11
00816870020655	CK-MB AccuBind ELISA Test System - 96 Wells	MONOBIND, INC.	2019-02-11
04015630939978	Elecsys CK-MB	Roche Diagnostics GmbH	2017-04-21
04015630939534	CalSet CK-MB	Roche Diagnostics GmbH	2017-04-17
M525552612	SPIFE CK-20,40 Gel Kit	HELENA LABORATORIES CORPORATION	2017-02-10
00842768015328	Dimension Vista® Flex® reagent cartridge MMB	Siemens Healthcare Diagnostics Inc.	2016-09-24
00842768013898	Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge	Siemens Healthcare Diagnostics Inc.	2016-09-24
00842768013829	Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge	Siemens Healthcare Diagnostics Inc.	2016-09-24
15099590011468	AU	Beckman Coulter, Inc.	2016-09-24
04015630934638	Elecsys CKMB STAT Immunoassay	Roche Diagnostics GmbH	2016-09-20
04015630934621	Elecsys CKMB Immunoassay	Roche Diagnostics GmbH	2016-09-20
04015630928729	Elecsys CKMB STAT CalSet	Roche Diagnostics GmbH	2016-09-20
M5255525900	Blade Applicator Kit, 20 Sample	HELENA LABORATORIES CORPORATION	2016-09-07
M5255525890	Blade Applicator Kit, 20 Sample	HELENA LABORATORIES CORPORATION	2016-09-07
M5255523960	QuickGel CK Vis Gel Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255520280	SPIFE CK Reagent Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255520150	SPIFE CK-20,40 Gel Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255517650	Blade Applicator Kit, 20 Sample	HELENA LABORATORIES CORPORATION	2016-09-07
M5255516740	Blade Applicator Kit, 20 Sample	HELENA LABORATORIES CORPORATION	2016-09-07

Product code JHY

Related 510(k) Records#

Related GUDID Devices#