Immpulse Coated Tube Phenytoin Assay Reagents
FDA 510(k) K865102 · Sclavo, Inc.
510(k) numberK865102
Submission
- Device name
- Immpulse Coated Tube Phenytoin Assay Reagents
- Applicant
- Sclavo, Inc.
Sunnyvale, CA, US - Received
- December 24, 1986
- Decision date
- January 13, 1987
- 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 |
|---|---|---|---|
| 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 |
| K813538 | Phenytoin Fluorescent ImmunoassayLES · Traditional | American Diagnostic Corp. | 12/31/1981SE |
| 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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| K880049 | Cholinesterase - Butyrythiocholine SubstrateDIH · Traditional | 01/27/1989SE |
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Questions and answers
When was Immpulse Coated Tube Phenytoin Assay Reagents cleared by the FDA?
Immpulse Coated Tube Phenytoin Assay Reagents (K865102) received a 510(k) decision of Substantially Equivalent on January 13, 1987, 20 days after the submission was received.
What is the product code of K865102?
The FDA product code is LES – Fluorescent Immunoassay, Diphenylhydantoin, a Class II (moderate risk) device regulated under 21 CFR 862.3350.