JHY — Colorimetric Method, Cpk Or Isoenzymes Class II
FDA product code JHY covers "Colorimetric Method, Cpk Or Isoenzymes", a Class II medical device regulated under 21 CFR 862.1215. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |