ANALYZER-SUPPLEMENT, KINETIC, LKB 2086
FDA 510(k) clearance K780461 · decided 1978-04-12
Clearance details
- K-number
- K780461
- Device name
- ANALYZER-SUPPLEMENT, KINETIC, LKB 2086
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1978-03-23
- Decision date
- 1978-04-12
- 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
- Mchenry, 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 |
| TDX ETHOSUXIMIDE (K850174) | Abbott Laboratories | 1985-02-06 |
| 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, FAST, CENTRIFUGAL, GEMSAEC (K780380) | Syva Co. | 1978-04-12 |
Recalls involving this device
No recalls on record reference this clearance.