Ames Tda Ethosuximide Test
FDA 510(k) K823801 · Miles Laboratories, Inc.
510(k) numberK823801
Submission
- Device name
- Ames Tda Ethosuximide Test
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- December 17, 1982
- Decision date
- January 14, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DLF – Enzyme Immunoassay, Ethosuximide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3380
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DLF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881607 | Easy-Test Emit(R) Ethosuximide (Eths) Item 16647DLF · Traditional | Em Diagnostic Systems, Inc. | 06/01/1988SE |
| K850174 | TDX EthosuximideDLF · Traditional | Abbott Laboratories | 02/06/1985SE |
| K844204 | Emit QST Ethosuximide AssayDLF · Traditional | Syva Co. | 12/11/1984SE |
| K832797 | Modifica- of Emit AED Ethosuximide AssayDLF · Traditional | Syva Co. | 09/29/1983SE |
| K823745 | Advance Emit-Aed EthosuximideDLF · Traditional | Syva Co. | 01/07/1983SE |
| K792584 | Aca Ethosurimide Test PackDLF · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 12/31/1979SE |
| K780461 | Analyzer-Supplement, Kinetic, LKB 2086DLF · Traditional | Syva Co. | 04/12/1978SE |
| K780380 | Analyzer, Fast, Centrifugal, GemsaecDLF · Traditional | Syva Co. | 04/12/1978SE |
More from Syva Co.
| 510(k) | Device | Decision |
|---|---|---|
| K880605 | Labeling Change for Cutter Pureflo Plus IV FilterFPB · Traditional | 05/26/1988SE |
| K874909 | Micro-Bumintest Reagent TabletsJIR · Traditional | 04/28/1988SE |
| K875079 | Modified Seralyzer Alt/Sgpt Reag. Strips & ModuleCKA · Traditional | 04/05/1988SE |
| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
| K872120 | Seralyzer III Blood Chemistry AnalyzerJJF · Traditional | 10/28/1987SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | 09/11/1987SE |
| K872634 | Cutter Pureflo Plus IV FilterFPB · Traditional | 08/04/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | 02/18/1987SE |
Questions and answers
When was Ames Tda Ethosuximide Test cleared by the FDA?
Ames Tda Ethosuximide Test (K823801) received a 510(k) decision of Substantially Equivalent on January 14, 1983, 28 days after the submission was received.
What is the product code of K823801?
The FDA product code is DLF – Enzyme Immunoassay, Ethosuximide, a Class II (moderate risk) device regulated under 21 CFR 862.3380.