Analyzer, Fast, Centrifugal, Gemsaec
FDA 510(k) K780380 · Syva Co.
510(k) numberK780380
Submission
- Device name
- Analyzer, Fast, Centrifugal, Gemsaec
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- March 10, 1978
- Decision date
- April 12, 1978
- 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 |
| K823801 | Ames Tda Ethosuximide TestDLF · Traditional | Miles Laboratories, Inc. | 01/14/1983SE |
| 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 |
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Questions and answers
When was Analyzer, Fast, Centrifugal, Gemsaec cleared by the FDA?
Analyzer, Fast, Centrifugal, Gemsaec (K780380) received a 510(k) decision of Substantially Equivalent on April 12, 1978, 33 days after the submission was received.
What is the product code of K780380?
The FDA product code is DLF – Enzyme Immunoassay, Ethosuximide, a Class II (moderate risk) device regulated under 21 CFR 862.3380.