TDX PRIMIDONE
FDA 510(k) clearance K813597 · decided 1982-01-22
Clearance details
- K-number
- K813597
- Device name
- TDX PRIMIDONE
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1981-12-28
- Decision date
- 1982-01-22
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- DJD
- Device class
- 2
- Regulation number
- 862.3680
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Abbott Park, IL, 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 |
| AMES TDA PRIMIDONE TEST (K802654) | Miles Laboratories, Inc. | 1980-11-12 |
| 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 |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |