The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Immpulse Phenytoin Assay Reagent.
| Device ID | K862554 |
| 510k Number | K862554 |
| Device Name: | IMMPULSE PHENYTOIN ASSAY REAGENT |
| Classification | Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) |
| Applicant | SCLAVO, INC. 1240 ELKO DR. Sunnyvale, CA 94089 |
| Contact | Michael Brinkley |
| Correspondent | Michael Brinkley SCLAVO, INC. 1240 ELKO DR. Sunnyvale, CA 94089 |
| Product Code | LGR |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-03 |
| Decision Date | 1986-07-16 |