The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit 2000 Valproic Acid Assay, Model Osr4g229ul.
| Device ID | K011947 |
| 510k Number | K011947 |
| Device Name: | EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL |
| Classification | Enzyme Immunoassay, Valproic Acid |
| Applicant | SYVA CO. 20400 MARIANI AVE. Cupertino, CA 95014 |
| Contact | Susan L Collins |
| Correspondent | Susan L Collins SYVA CO. 20400 MARIANI AVE. Cupertino, CA 95014 |
| Product Code | LEG |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-21 |
| Decision Date | 2001-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768023248 | K011947 | 000 |