JHS — Differential Rate Kinetic Method, Cpk Or Isoenzymes Class II
FDA product code JHS covers "Differential Rate Kinetic 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
- JHS
- 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 |
|---|---|---|---|
| K160570 | roche diagnostics operations (rdo) | Creatine Kinase | May 25, 2016 |
| K102706 | sentinel ch | CKMB UDR ASSAY | August 19, 2011 |
| K082226 | alfa wassermann diagnostic technologies | S40 CREATINE KINASE (CK) | September 18, 2008 |
| K062128 | dade behring | THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS | August 21, 2006 |
| K990439 | careside | CARESIDE CK | April 19, 1999 |
| K990434 | careside | CARESIDE CKMB | April 19, 1999 |
| K981495 | diagnostic products | IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) | June 10, 1998 |
| K962126 | ciba corning diagnostics | ACS CKMB II IMMUNOASSAY | June 21, 1996 |
| K952250 | dade intl | STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIME | July 17, 1995 |
| K945083 | bio-rad laboratories | ACCESS CK-MB REAGENTS | November 21, 1994 |
| K943024 | dupont medical products | KINASE ISOENZYME | August 2, 1994 |
| K941584 | dupont medical products | CREATINE KINASE METHOD | July 6, 1994 |
| K903025 | roche diagnostic systems | ROCHE ISOMUNE- CK | August 9, 1990 |
| K900806 | baxter healthcare | STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY | March 23, 1990 |
| K883223 | intl. immunoassay laboratories | CHECK-MM | September 30, 1988 |
| K872029 | sclavo | UNI-FAST CREATINE KINASE TEST (CK) | June 17, 1987 |
| K861387 | eastman kodak | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB) | June 27, 1986 |
| K855188 | technostics intl | CPK (UV) REAGENT KIT | March 5, 1986 |
| K854708 | coulter electronics | DART CK-MB REAGENT SYSTEM | December 30, 1985 |
| K843007 | intl. immunoassay laboratories | CARDI-CK EIA TEST KIT CK-MB ISOENZYME | September 7, 1984 |