AMES TDA ETHOSUXIMIDE TEST
FDA 510(k) clearance K823801 · decided 1983-01-14
Clearance details
- K-number
- K823801
- Device name
- AMES TDA ETHOSUXIMIDE TEST
- Applicant
- Miles Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-12-17
- Decision date
- 1983-01-14
- Days to decision
- 28 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
+ Add to Predicate Builder ◉ Watch Miles Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| 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 |
|---|---|---|
| BIOSTATOR GLUCOSE CONTROLLER (P800032/S001) | Miles Laboratories, Inc. | 1983-06-02 |
| BIOSTATOR GLUCOSE CONTROLLER (P800032) | Miles Laboratories, Inc. | 1981-05-28 |