Phenytoin Fluorescent Immunoassay
FDA 510(k) K813538 · American Diagnostic Corp.
510(k) numberK813538
Submission
- Device name
- Phenytoin Fluorescent Immunoassay
- Applicant
- American Diagnostic Corp.
Walker, MI, US - Received
- December 21, 1981
- Decision date
- December 31, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LES – Fluorescent Immunoassay, Diphenylhydantoin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3350
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LES
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K865102 | Immpulse Coated Tube Phenytoin Assay ReagentsLES · Traditional | Sclavo, Inc. | 01/13/1987SE |
| K844990 | Syva Advance Emit Phenytoin AssayLES · Traditional | Syva Co. | 01/23/1985SE |
| K831154 | Stratus Phenytoin Fluorometric EnzymeLES · Traditional | American Dade | 05/16/1983SE |
| K820187 | Syva Advance Sys. Emit,(R)-Aed(R) PhenyLES · Traditional | Syva Co. | 02/12/1982SE |
| K811025 | Ames Tda TM Phenytoin TestLES · Traditional | Miles Laboratories, Inc. | 04/29/1981SE |
| K801736 | Ames Tda TM Phenytoin TestLES · Traditional | Miles Laboratories, Inc. | 08/20/1980SE |
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Questions and answers
When was Phenytoin Fluorescent Immunoassay cleared by the FDA?
Phenytoin Fluorescent Immunoassay (K813538) received a 510(k) decision of Substantially Equivalent on December 31, 1981, 10 days after the submission was received.
What is the product code of K813538?
The FDA product code is LES – Fluorescent Immunoassay, Diphenylhydantoin, a Class II (moderate risk) device regulated under 21 CFR 862.3350.