The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Valproic Acid Eia Test.
| Device ID | K961988 |
| 510k Number | K961988 |
| Device Name: | VALPROIC ACID EIA TEST |
| Classification | Enzyme Immunoassay, Valproic Acid |
| Applicant | DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. Sunnyvale, CA 94086 |
| Contact | Yug-geng Tsay, Ph.d. |
| Correspondent | Yug-geng Tsay, Ph.d. DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. Sunnyvale, CA 94086 |
| Product Code | LEG |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-21 |
| Decision Date | 1996-07-16 |