Panels › Clinical Chemistry › Product code JHW · Class 2
U.V. Method, Cpk Isoenzymes
Regulation 862.1215
0510(k)s in 12 months (27 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in JHW
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 26, 2017 | K162526 | Creatine Kinase-MB Roche Diagnostics | JHW |
| Jul 18, 2014 | K141265 | ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT Elitechgroup | JHW |
| Aug 22, 2012 | K122083 | ELITECH CLINICAL SYSTEMS CK NAC SL Elitechgroup | JHW |
| Jan 3, 2003 | K023744 | WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 Wiener Laboratories Saic, AR | JHW |
| Dec 18, 2000 | K003158 | ROCHE DIAGNOSTICS CK-MB Roche Diagnostics Corp. | JHW |
| Jun 11, 1996 | K961501 | ELECSYS CK-MB Boehringer Mannheim Corp. | JHW |
| Mar 13, 1995 | K950186 | CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM Miles, Inc. | JHW |
| Feb 22, 1995 | K944325 | LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN Princeton BioMeditech Corp. | JHW |
| Nov 21, 1994 | K942958 | CREATINE KINASE MB DETERMINATION (UV) Biochemical Trade, Inc. | JHW |
| Jun 21, 1994 | K935924 | AXSYM CK-MB Abbott Laboratories | JHW |
| Apr 20, 1993 | K931050 | CARDIO REP CK ISOENZYME KIT - 3310 Helena Laboratories | JHW |
| Oct 23, 1991 | K913349 | STAMBI-CK Intl. Immunoassay Laboratories, Inc. | JHW |
| Jul 8, 1991 | K912231 | PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT Intl. Immunoassay Laboratories, Inc. | JHW |
| Jan 17, 1991 | K905588 | CREATINE KINASE UV REAGENT SET Biochemical Trade, Inc. | JHW |
| Sep 7, 1990 | K903508 | LABELLING CHANGES TO IMPRES-MB-X Intl. Immunoassay Laboratories, Inc. | JHW |
| Sep 30, 1988 | K883222 | ISOFOR-MM (TM) Intl. Immunoassay Laboratories, Inc. | JHW |
| Jun 8, 1988 | K881801 | IMPRES-MB Intl. Immunoassay Laboratories, Inc. | JHW |
| Dec 15, 1982 | K822897 | DSL 1700 Diagnostic Systems Laboratories, Inc. | JHW |
| Jun 25, 1981 | K811575 | CARDIOZYME PLUS CK-MB ITEM #65045 (G) Harleco | JHW |
| Jun 25, 1981 | K811573 | CARDIOZYME PLUS CK-MB ITEM #65045 Harleco | JHW |
| Apr 14, 1981 | K810905 | ISOMUNE-CK Hoffmann-La Roche, Inc. | JHW |
| Apr 14, 1981 | K810861 | CREATINE KINASE MB ISOENZYME IMMUNO UV The Dow Chemical Co. | JHW |
| Jan 9, 1981 | K803168 | CARDIO ZYME PLUS CK-MB #65045 Harleco | JHW |
| Jan 11, 1980 | K792533 | CREATINE PHOSPHOKINASE (CPK) REAGENT SET Macomb Chemical Co. | JHW |
| Feb 1, 1979 | K782015 | A-GENT CK-MB Abbott Laboratories | JHW |
| Aug 10, 1978 | K781124 | CPK ISOENZYME REAGENT Electrophoresis Corp. of America | JHW |
| Dec 6, 1977 | K772172 | DYNAZYME TM II CARDIAK-MB J.T. Baker Chemical Co. | JHW |
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