Product code JHW

Device name: U.V. Method, Cpk 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
K162526	Creatine Kinase-MB	Roche Diagnostics	2017-05-26
K141265	ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT	Elitechgroup	2014-07-18
K122083	ELITECH CLINICAL SYSTEMS CK NAC SL	Elitechgroup	2012-08-22
K023744	WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354	Wiener Laboratories Saic	2003-01-03
K003158	ROCHE DIAGNOSTICS CK-MB	Roche Diagnostics Corp.	2000-12-18
K961501	ELECSYS CK-MB	Boehringer Mannheim Corp.	1996-06-11
K950186	CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM	Miles, Inc.	1995-03-13
K944325	LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN	Princeton BioMeditech Corp.	1995-02-22
K942958	CREATINE KINASE MB DETERMINATION (UV)	Biochemical Trade, Inc.	1994-11-21
K935924	AXSYM CK-MB	Abbott Laboratories	1994-06-21
K931050	CARDIO REP CK ISOENZYME KIT - 3310	Helena Laboratories	1993-04-20
K913349	STAMBI-CK	Intl. Immunoassay Laboratories, Inc.	1991-10-23
K912231	PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT	Intl. Immunoassay Laboratories, Inc.	1991-07-08
K905588	CREATINE KINASE UV REAGENT SET	Biochemical Trade, Inc.	1991-01-17
K903508	LABELLING CHANGES TO IMPRES-MB-X	Intl. Immunoassay Laboratories, Inc.	1990-09-07
K883222	ISOFOR-MM (TM)	Intl. Immunoassay Laboratories, Inc.	1988-09-30
K881801	IMPRES-MB	Intl. Immunoassay Laboratories, Inc.	1988-06-08
K822897	DSL 1700	Diagnostic Systems Laboratories, Inc.	1982-12-15
K811573	CARDIOZYME PLUS CK-MB ITEM #65045	Harleco	1981-06-25
K811575	CARDIOZYME PLUS CK-MB ITEM #65045 (G)	Harleco	1981-06-25
K810861	CREATINE KINASE MB ISOENZYME IMMUNO UV	The Dow Chemical Co.	1981-04-14
K810905	ISOMUNE-CK	Hoffmann-La Roche, Inc.	1981-04-14
K803168	CARDIO ZYME PLUS CK-MB #65045	Harleco	1981-01-09
K792533	CREATINE PHOSPHOKINASE (CPK) REAGENT SET	Macomb Chemical Co.	1980-01-11
K782015	A-GENT CK-MB	Abbott Laboratories	1979-02-01
K781124	CPK ISOENZYME REAGENT	Electrophoresis Corp. of America	1978-08-10
K772172	DYNAZYME TM II CARDIAK-MB	J.T. Baker Chemical Co.	1977-12-06

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00811727018632	Pointe Scientific CK-MB	HORIBA INSTRUMENTS INCORPORATED	2021-02-28
00811727018649	Pointe Scientific CK-MB	HORIBA INSTRUMENTS INCORPORATED	2021-02-28
00657498001547	CK-MB Liqui-UV®	STANBIO LABORATORY, L.P.	2016-10-11
00657498000748	CK-MB Test	STANBIO LABORATORY, L.P.	2016-09-23
00817274021293	JAS Diagnostics	DREW SCIENTIFIC, INC.	2016-09-09
00817274021309	JAS Diagnostics	DREW SCIENTIFIC, INC.	2016-09-09
00817274021316	JAS Diagnostics	DREW SCIENTIFIC, INC.	2016-09-09
00811727010940	POINTE SCIENTIFIC CK-MB	HORIBA INSTRUMENTS INCORPORATED	2016-08-31
00811727010957	POINTE SCIENTIFIC CK-MB	HORIBA INSTRUMENTS INCORPORATED	2016-08-31
00811727010964	POINTE SCIENTIFIC CK-MB	HORIBA INSTRUMENTS INCORPORATED	2016-08-31

Product code JHW

Related 510(k) Records#

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