JMK — Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase Class I
FDA Device Classification
Classification Details
- Product Code
- JMK
- Device Class
- Class I
- Regulation Number
- 862.1380
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K983860 | polymer technology systems | MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 | December 27, 1999 |
| K981865 | polymer technology systems | MTM BIOSCANNER K TEST STRIPS | February 26, 1999 |
| K953452 | ihara medics u.s | KETOREX C SANWA | May 2, 1996 |
| K941427 | teco diagnostics | SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) | March 13, 1995 |
| K862319 | sigma chemical | HBDH (OPTIMIZED) REAGENT | July 7, 1986 |
| K843774 | reagents applications | RAICHEM X-HBDH REAGENT | October 31, 1984 |
| K822739 | gilford diagnostics | AHBD | October 18, 1982 |
| K821877 | harleco diagnostics | ULTRAZYME PLUS HBD | July 14, 1982 |
| K781720 | medical analysis systems | HBDH ENZYME KINETIC REAGENT SET | November 3, 1978 |
| K780104 | harleco | ULTRAZYME PLUS HBD | February 13, 1978 |
| K780073 | medical analysis systems | HBDH REAGENT SET | February 13, 1978 |
| K780042 | beckman instruments | HYDORRYBUTYRATE DEHYDROGENASE | February 1, 1978 |
| K772033 | harleco | GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP* | November 17, 1977 |
| K771474 | instrumentation laboratory | MULTISTAT III X-HBDH TEST | September 13, 1977 |
| K770871 | harleco | ULTRAZYME PLUS HBD | July 14, 1977 |
| K760023 | harleco | ULTRAZYME HBD | August 26, 1976 |