JHW — U.V. Method, Cpk Isoenzymes Class II
FDA Device Classification
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 |