AMES TDA PRIMIDONE TEST
FDA 510(k) clearance K802654 · decided 1980-11-12
Clearance details
- K-number
- K802654
- Device name
- AMES TDA PRIMIDONE TEST
- Applicant
- Miles Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-10-24
- Decision date
- 1980-11-12
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- DJD
- Device class
- 2
- Regulation number
- 862.3680
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Walker, MI, 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 |
|---|---|---|
| ACE PRIMIDONE REAGENT, AED CALIBRATORS (K973582) | Schiapparelli Biosystems, Inc. | 1997-11-12 |
| EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE (K910527) | Syva Co. | 1991-03-14 |
| EMIT QST PRIMIDONE ASSAY (K840939) | Syva Co. | 1984-04-24 |
| MODIFICA-OF EMIT AED PRIMIDONE ASSAY (K832798) | Syva Co. | 1983-10-14 |
| PRIMIDONE REAGENT TEST KIT (K820138) | Beckman Instruments, Inc. | 1982-01-28 |
| TDX PRIMIDONE (K813597) | Abbott Laboratories | 1982-01-22 |
| ANALYTICAL TEST PACK, PRIMIDONE (K781957) | E.I. Dupont DE Nemours & Co., Inc. | 1979-01-10 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIOSTATOR GLUCOSE CONTROLLER (P800032/S001) | Miles Laboratories, Inc. | 1983-06-02 |
| BIOSTATOR GLUCOSE CONTROLLER (P800032) | Miles Laboratories, Inc. | 1981-05-28 |