TDX ETHOSUXIMIDE
FDA 510(k) clearance K850174 · decided 1985-02-06
Clearance details
- K-number
- K850174
- Device name
- TDX ETHOSUXIMIDE
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1985-01-17
- Decision date
- 1985-02-06
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- DLF
- Device class
- 2
- Regulation number
- 862.3380
- 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 |
|---|---|---|
| EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647 (K881607) | Em Diagnostic Systems, Inc. | 1988-06-01 |
| EMIT QST ETHOSUXIMIDE ASSAY (K844204) | Syva Co. | 1984-12-11 |
| MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAY (K832797) | Syva Co. | 1983-09-29 |
| AMES TDA ETHOSUXIMIDE TEST (K823801) | Miles Laboratories, Inc. | 1983-01-14 |
| ADVANCE EMIT-AED ETHOSUXIMIDE (K823745) | Syva Co. | 1983-01-07 |
| ACA ETHOSURIMIDE TEST PACK (K792584) | E.I. Dupont DE Nemours & Co., Inc. | 1979-12-31 |
| ANALYZER-SUPPLEMENT, KINETIC, LKB 2086 (K780461) | Syva Co. | 1978-04-12 |
| ANALYZER, FAST, CENTRIFUGAL, GEMSAEC (K780380) | Syva Co. | 1978-04-12 |
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 |