510(k) K850174
- Device
- Tdx Ethosuximide
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K850174
- Product code
- DLF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-02-06
- Date received
- 1985-01-17
- Regulation
- 862.3380
- Classification name
- Enzyme Immunoassay, Ethosuximide
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY E ZORC
- Address
- One Abbott Park Rd. Abbott Park IL US 60064 60064
FDA Registration Numbers#
- 2517506
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DLF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K881607 | EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647 | Em Diagnostic Systems, Inc. | 1988-06-01 |
| K844204 | EMIT QST ETHOSUXIMIDE ASSAY | Syva Co. | 1984-12-11 |
| K832797 | MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAY | Syva Co. | 1983-09-29 |
| K823801 | AMES TDA ETHOSUXIMIDE TEST | Miles Laboratories, Inc. | 1983-01-14 |
| K823745 | ADVANCE EMIT-AED ETHOSUXIMIDE | Syva Co. | 1983-01-07 |
| K792584 | ACA ETHOSURIMIDE TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1979-12-31 |
| K780380 | ANALYZER, FAST, CENTRIFUGAL, GEMSAEC | Syva Co. | 1978-04-12 |
| K780461 | ANALYZER-SUPPLEMENT, KINETIC, LKB 2086 | Syva Co. | 1978-04-12 |