SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)
FDA 510(k) clearance K941427 · decided 1995-03-13
Clearance details
- K-number
- K941427
- Device name
- SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)
- Applicant
- Teco Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1994-03-24
- Decision date
- 1995-03-13
- Days to decision
- 354 days
- Clearance type
- Traditional
- Product code
- JMK
- Device class
- 1
- Regulation number
- 862.1380
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Placentia, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 (K983860) | Polymer Technology Systems, Inc. | 1999-12-27 |
| MTM BIOSCANNER K TEST STRIPS (K981865) | Polymer Technology Systems, Inc. | 1999-02-26 |
| KETOREX C SANWA (K953452) | Ihara Medics U.S., Inc. | 1996-05-02 |
| HBDH (OPTIMIZED) REAGENT (K862319) | Sigma Chemical Co. | 1986-07-07 |
| RAICHEM X-HBDH REAGENT (K843774) | Reagents Applications, Inc. | 1984-10-31 |
| AHBD (K822739) | Gilford Diagnostics | 1982-10-18 |
| ULTRAZYME PLUS HBD (K821877) | Harleco Diagnostics | 1982-07-14 |
| HBDH ENZYME KINETIC REAGENT SET (K781720) | Medical Analysis Systems, Inc. | 1978-11-03 |
| ULTRAZYME PLUS HBD (K780104) | Harleco | 1978-02-13 |
| HBDH REAGENT SET (K780073) | Medical Analysis Systems, Inc. | 1978-02-13 |
| HYDORRYBUTYRATE DEHYDROGENASE (K780042) | Beckman Instruments, Inc. | 1978-02-01 |
| GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP* (K772033) | Harleco | 1977-11-17 |
Recalls involving this device
No recalls on record reference this clearance.