Panels › Clinical Chemistry › Product code JHY · Class 2
Colorimetric Method, Cpk Or Isoenzymes
Regulation 862.1215
0510(k)s in 12 months (40 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in JHY
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 18, 2015 | K143720 | Dimension Vista MMB Assay Siemens Healthcare Diagnostics | JHY |
| May 13, 2014 | K130080 | EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL Medica Corporation | JHY |
| May 8, 2014 | K140404 | ELECSYS CK-MB STAT IMMUNOASSAY Roche Diagnostics | JHY |
| Oct 18, 2013 | K132571 | ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY Roche Diagnostics | JHY |
| Jun 4, 2007 | K070835 | OLYMPUS CK-MB REAGENT Olympus Life & Material Science Europa GmbH (Irish, IE | JHY |
| Oct 11, 2002 | K022757 | SPIFE CK KIT, MODEL 3332, 3333 Helena Laboratories | JHY |
| Aug 29, 2002 | K022654 | MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB Roche Diagnostics Corp. | JHY |
| Dec 17, 1997 | K974421 | ELECSYS CK-MB STAT Boehringer Mannheim Corp. | JHY |
| Feb 14, 1997 | K970343 | MMB METHOD Dade Chemistry Systems, Inc. | JHY |
| Jun 18, 1996 | K961412 | CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO Bayer Corp. | JHY |
| May 2, 1995 | K951638 | AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK Organon Teknika Corp. | JHY |
| Jun 15, 1993 | K931172 | IMX(R) STAT CK-MB Abbott Laboratories | JHY |
| Oct 15, 1992 | K924429 | OPUS(R) CK-MB Pb Diagnostic Systems, Inc. | JHY |
| Aug 20, 1992 | K922700 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH. E.I. Dupont DE Nemours & Co., Inc. | JHY |
| Jun 9, 1992 | K921763 | TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY Hybritech, Inc. | JHY |
| Jul 17, 1991 | K912766 | AMERLITE CK-MB ASSAY Amersham Corp. | JHY |
| Feb 16, 1990 | K896240 | COBAS READY CK REAGENT Roche Diagnostic Systems, Inc. | JHY |
| Dec 1, 1989 | K895870 | ISOSCREEN-CK CONFIRMATORY KIT Roche Diagnostic Systems, Inc. | JHY |
| Aug 15, 1989 | K890295 | TARGET(TM) CK-MB V-Tech, Inc. | JHY |
| Feb 23, 1989 | K884550 | CREATINE KINASE MB ENZYME IMMUNOASSAY KIT Bd Becton Dickinson Vacutainer Systems Preanalytic | JHY |
| Dec 2, 1988 | K884085 | TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY Hybritech, Inc. | JHY |
| Aug 8, 1988 | K883013 | IMX CKMB Abbott Laboratories | JHY |
| Jun 1, 1988 | K881351 | IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225 Intl. Immunoassay Laboratories, Inc. | JHY |
| Feb 24, 1988 | K875192 | KODAK EKTACHEM DT SLIDES (CKMB) Eastman Kodak Company | JHY |
| Feb 18, 1988 | K880178 | CREATINE KINASE (COLORIMETRIC METHOD) Tech-Co, Inc. | JHY |
| Dec 18, 1987 | K874545 | IMACK-MB TEST PROCEDURE (MODIFICATION) Intl. Immunoassay Laboratories, Inc. | JHY |
| Jun 19, 1987 | K872063 | TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II Hybritech, Inc. | JHY |
| May 12, 1987 | K871677 | CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS Catachem, Inc. | JHY |
| Apr 11, 1986 | K860663 | AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT Amresco, Inc. | JHY |
| Jan 18, 1985 | K845024 | BAKER CKMB REAGENT SET Hybritech, Inc. | JHY |
| Apr 5, 1984 | K832977 | FLOW-PAC CPK REAGENT SET American Research Products Co. | JHY |
| Aug 12, 1983 | K832139 | TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY Hybritech, Inc. | JHY |
| Aug 11, 1983 | K832004 | WAKO CPK TEST Wako Chemicals USA, Inc. | JHY |
| Apr 5, 1983 | K830672 | CREATINE KINASE REAGENT SET Sterling Biochemical, Inc. | JHY |
| Apr 12, 1982 | K820812 | CREATINE KINASE-MB KIT Calbiochem-Behring Corp. | JHY |
| May 28, 1980 | K800684 | REAGENT FOR DETERM. CREATINE PHOSPHOKINA Diagnostic Solutions, Inc. | JHY |
| Sep 17, 1979 | K791655 | CPK ISOENZYME REAGENT Electrophoresis Corp. of America | JHY |
| Apr 4, 1979 | K790309 | CPK ISOENZYME SUBSTRATE Electrophoresis Corp. | JHY |
| Dec 21, 1976 | K761212 | CPK1SOENZYMES DETERMINATION PRO. #715-EP Sigma Chemical Co. | JHY |
| Nov 2, 1976 | K760871 | LANCER MB/CPK ISOENZYME KIT Sherwood Medical Industries | JHY |
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