The following data is part of a premarket notification filed by Seradyn with the FDA for Qms / Multigent Valproic Acid Reagent, Part #396075.
| Device ID | K030405 |
| 510k Number | K030405 |
| Device Name: | QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 |
| Classification | Enzyme Immunoassay, Valproic Acid |
| Applicant | SERADYN 7998 GEORGETOWN RD. SUITE 1000 Indianapolis, IN 46268 |
| Contact | Les Padilla |
| Correspondent | Les Padilla SERADYN 7998 GEORGETOWN RD. SUITE 1000 Indianapolis, IN 46268 |
| Product Code | LEG |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-06 |
| Decision Date | 2003-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740154158 | K030405 | 000 |
| 00380740000332 | K030405 | 000 |