FDA Product Code
FDA Product Code JMK — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1380
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K983860 | MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 | Polymer Technology Systems, Inc. | 1999-12-27 | Traditional | PDF ↗ |
| K981865 | MTM BIOSCANNER K TEST STRIPS | Polymer Technology Systems, Inc. | 1999-02-26 | Traditional | PDF ↗ |
| K953452 | KETOREX C SANWA | Ihara Medics U.S., Inc. | 1996-05-02 | Traditional | PDF ↗ |
| K941427 | SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) | Teco Diagnostics | 1995-03-13 | Traditional | PDF ↗ |
| K862319 | HBDH (OPTIMIZED) REAGENT | Sigma Chemical Co. | 1986-07-07 | Traditional | PDF ↗ |
| K843774 | RAICHEM X-HBDH REAGENT | Reagents Applications, Inc. | 1984-10-31 | Traditional | PDF ↗ |
| K822739 | AHBD | Gilford Diagnostics | 1982-10-18 | Traditional | PDF ↗ |
| K821877 | ULTRAZYME PLUS HBD | Harleco Diagnostics | 1982-07-14 | Traditional | PDF ↗ |
| K781720 | HBDH ENZYME KINETIC REAGENT SET | Medical Analysis Systems, Inc. | 1978-11-03 | Traditional | PDF ↗ |
| K780073 | HBDH REAGENT SET | Medical Analysis Systems, Inc. | 1978-02-13 | Traditional | PDF ↗ |
| K780104 | ULTRAZYME PLUS HBD | Harleco | 1978-02-13 | Traditional | PDF ↗ |
| K780042 | HYDORRYBUTYRATE DEHYDROGENASE | Beckman Instruments, Inc. | 1978-02-01 | Traditional | PDF ↗ |
| K772033 | GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP* | Harleco | 1977-11-17 | Traditional | PDF ↗ |
| K771474 | MULTISTAT III X-HBDH TEST | Instrumentation Laboratory CO | 1977-09-13 | Traditional | PDF ↗ |
| K770871 | ULTRAZYME PLUS HBD | Harleco | 1977-07-14 | Traditional | PDF ↗ |
| K760023 | ULTRAZYME HBD | Harleco | 1976-08-26 | Traditional | PDF ↗ |
Product code JMK · Class I · Clinical Chemistry. Data: openFDA.