JHW — U.V. Method, Cpk Isoenzymes Class II
FDA product code JHW covers "U.V. Method, Cpk 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
- JHW
- 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 |
|---|---|---|---|
| K162526 | roche diagnostics | Creatine Kinase-MB | May 26, 2017 |
| K141265 | elitechgroup | ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT | July 18, 2014 |
| K122083 | elitechgroup | ELITECH CLINICAL SYSTEMS CK NAC SL | August 22, 2012 |
| K023744 | wiener laboratories saic | WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 | January 3, 2003 |
| K003158 | roche diagnostics | ROCHE DIAGNOSTICS CK-MB | December 18, 2000 |
| K961501 | boehringer mannheim | ELECSYS CK-MB | June 11, 1996 |
| K950186 | miles | CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM | March 13, 1995 |
| K944325 | princeton biomeditech | LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN | February 22, 1995 |
| K942958 | biochemical trade | CREATINE KINASE MB DETERMINATION (UV) | November 21, 1994 |
| K935924 | abbott laboratories | AXSYM CK-MB | June 21, 1994 |
| K931050 | helena laboratories | CARDIO REP CK ISOENZYME KIT - 3310 | April 20, 1993 |
| K913349 | intl. immunoassay laboratories | STAMBI-CK | October 23, 1991 |
| K912231 | intl. immunoassay laboratories | PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT | July 8, 1991 |
| K905588 | biochemical trade | CREATINE KINASE UV REAGENT SET | January 17, 1991 |
| K903508 | intl. immunoassay laboratories | LABELLING CHANGES TO IMPRES-MB-X | September 7, 1990 |
| K883222 | intl. immunoassay laboratories | ISOFOR-MM (TM) | September 30, 1988 |
| K881801 | intl. immunoassay laboratories | IMPRES-MB | June 8, 1988 |
| K822897 | diagnostic systems laboratories | DSL 1700 | December 15, 1982 |
| K811575 | harleco | CARDIOZYME PLUS CK-MB ITEM #65045 (G) | June 25, 1981 |
| K811573 | harleco | CARDIOZYME PLUS CK-MB ITEM #65045 | June 25, 1981 |