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 |