JHY — Colorimetric Method, Cpk Or Isoenzymes Class II
FDA Device Classification
Classification Details
- Product Code
- JHY
- Device Class
- Class II
- Regulation Number
- 862.1215
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K143720 | siemens healthcare diagnostics | Dimension Vista MMB Assay | September 18, 2015 |
| K130080 | medica corporation | EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CR | May 13, 2014 |
| K140404 | roche diagnostics | ELECSYS CK-MB STAT IMMUNOASSAY | May 8, 2014 |
| K132571 | roche diagnostics | ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY | October 18, 2013 |
| K070835 | olympus life and material science europa gmbh (irish | OLYMPUS CK-MB REAGENT | June 4, 2007 |
| K022757 | helena laboratories | SPIFE CK KIT, MODEL 3332, 3333 | October 11, 2002 |
| K022654 | roche diagnostics | MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB | August 29, 2002 |
| K974421 | boehringer mannheim | ELECSYS CK-MB STAT | December 17, 1997 |
| K970343 | dade chemistry systems | MMB METHOD | February 14, 1997 |
| K961412 | bayer | CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO | June 18, 1996 |
| K951638 | organon teknika | AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK | May 2, 1995 |
| K931172 | abbott laboratories | IMX(R) STAT CK-MB | June 15, 1993 |
| K924429 | pb diagnostic systems | OPUS(R) CK-MB | October 15, 1992 |
| K922700 | e.i. dupont de nemours and co | DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH. | August 20, 1992 |
| K921763 | hybritech | TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY | June 9, 1992 |
| K912766 | amersham | AMERLITE CK-MB ASSAY | July 17, 1991 |
| K896240 | roche diagnostic systems | COBAS READY CK REAGENT | February 16, 1990 |
| K895870 | roche diagnostic systems | ISOSCREEN-CK CONFIRMATORY KIT | December 1, 1989 |
| K890295 | v-tech | TARGET(TM) CK-MB | August 15, 1989 |
| K884550 | bd becton dickinson vacutainer systems preanalytic | CREATINE KINASE MB ENZYME IMMUNOASSAY KIT | February 23, 1989 |