FDA Product Code
FDA Product Code JHY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1215
510(k) Clearances — 40 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K143720 | Dimension Vista MMB Assay | Siemens Healthcare Diagnostics | 2015-09-18 | Traditional | PDF ↗ |
| K130080 | EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL | Medica Corporation | 2014-05-13 | Traditional | PDF ↗ |
| K140404 | ELECSYS CK-MB STAT IMMUNOASSAY | Roche Diagnostics | 2014-05-08 | Special | PDF ↗ |
| K132571 | ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY | Roche Diagnostics | 2013-10-18 | Traditional | PDF ↗ |
| K070835 | OLYMPUS CK-MB REAGENT | Olympus Life & Material Science Europa GmbH (Irish | 2007-06-04 | Traditional | PDF ↗ |
| K022757 | SPIFE CK KIT, MODEL 3332, 3333 | Helena Laboratories | 2002-10-11 | Traditional | PDF ↗ |
| K022654 | MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB | Roche Diagnostics Corp. | 2002-08-29 | Special | PDF ↗ |
| K974421 | ELECSYS CK-MB STAT | Boehringer Mannheim Corp. | 1997-12-17 | Traditional | PDF ↗ |
| K970343 | MMB METHOD | Dade Chemistry Systems, Inc. | 1997-02-14 | Traditional | PDF ↗ |
| K961412 | CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO | Bayer Corp. | 1996-06-18 | Traditional | PDF ↗ |
| K951638 | AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK | Organon Teknika Corp. | 1995-05-02 | Traditional | PDF ↗ |
| K931172 | IMX(R) STAT CK-MB | Abbott Laboratories | 1993-06-15 | Traditional | PDF ↗ |
| K924429 | OPUS(R) CK-MB | Pb Diagnostic Systems, Inc. | 1992-10-15 | Traditional | PDF ↗ |
| K922700 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH. | E.I. Dupont DE Nemours & Co., Inc. | 1992-08-20 | Traditional | PDF ↗ |
| K921763 | TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1992-06-09 | Traditional | PDF ↗ |
| K912766 | AMERLITE CK-MB ASSAY | Amersham Corp. | 1991-07-17 | Traditional | PDF ↗ |
| K896240 | COBAS READY CK REAGENT | Roche Diagnostic Systems, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K895870 | ISOSCREEN-CK CONFIRMATORY KIT | Roche Diagnostic Systems, Inc. | 1989-12-01 | Traditional | PDF ↗ |
| K890295 | TARGET(TM) CK-MB | V-Tech, Inc. | 1989-08-15 | Traditional | PDF ↗ |
| K884550 | CREATINE KINASE MB ENZYME IMMUNOASSAY KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-02-23 | Traditional | PDF ↗ |
| K884085 | TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1988-12-02 | Traditional | PDF ↗ |
| K883013 | IMX CKMB | Abbott Laboratories | 1988-08-08 | Traditional | PDF ↗ |
| K881351 | IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225 | Intl. Immunoassay Laboratories, Inc. | 1988-06-01 | Traditional | PDF ↗ |
| K875192 | KODAK EKTACHEM DT SLIDES (CKMB) | Eastman Kodak Company | 1988-02-24 | Traditional | PDF ↗ |
| K880178 | CREATINE KINASE (COLORIMETRIC METHOD) | Tech-Co, Inc. | 1988-02-18 | Traditional | PDF ↗ |
| K874545 | IMACK-MB TEST PROCEDURE (MODIFICATION) | Intl. Immunoassay Laboratories, Inc. | 1987-12-18 | Traditional | PDF ↗ |
| K872063 | TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II | Hybritech, Inc. | 1987-06-19 | Traditional | PDF ↗ |
| K871677 | CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS | Catachem, Inc. | 1987-05-12 | Traditional | PDF ↗ |
| K860663 | AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT | Amresco, Inc. | 1986-04-11 | Traditional | PDF ↗ |
| K845024 | BAKER CKMB REAGENT SET | Hybritech, Inc. | 1985-01-18 | Traditional | PDF ↗ |
| K832977 | FLOW-PAC CPK REAGENT SET | American Research Products Co. | 1984-04-05 | Traditional | PDF ↗ |
| K832139 | TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K832004 | WAKO CPK TEST | Wako Chemicals USA, Inc. | 1983-08-11 | Traditional | PDF ↗ |
| K830672 | CREATINE KINASE REAGENT SET | Sterling Biochemical, Inc. | 1983-04-05 | Traditional | PDF ↗ |
| K820812 | CREATINE KINASE-MB KIT | Calbiochem-Behring Corp. | 1982-04-12 | Traditional | PDF ↗ |
| K800684 | REAGENT FOR DETERM. CREATINE PHOSPHOKINA | Diagnostic Solutions, Inc. | 1980-05-28 | Traditional | PDF ↗ |
| K791655 | CPK ISOENZYME REAGENT | Electrophoresis Corp. of America | 1979-09-17 | Traditional | PDF ↗ |
| K790309 | CPK ISOENZYME SUBSTRATE | Electrophoresis Corp. | 1979-04-04 | Traditional | PDF ↗ |
| K761212 | CPK1SOENZYMES DETERMINATION PRO. #715-EP | Sigma Chemical Co. | 1976-12-21 | Traditional | PDF ↗ |
| K760871 | LANCER MB/CPK ISOENZYME KIT | Sherwood Medical Industries | 1976-11-02 | Traditional | PDF ↗ |
Product code JHY · Class II · Clinical Chemistry. Data: openFDA.