The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Valproic Acid.
| Device ID | K936208 |
| 510k Number | K936208 |
| Device Name: | VALPROIC ACID |
| Classification | Enzyme Immunoassay, Valproic Acid |
| Applicant | SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Contact | Andris Indriksons |
| Correspondent | Andris Indriksons SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Product Code | LEG |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-29 |
| Decision Date | 1994-03-11 |