The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia Valporic Acid Assay.
| Device ID | K930734 |
| 510k Number | K930734 |
| Device Name: | CEDIA VALPORIC ACID ASSAY |
| Classification | Enzyme Immunoassay, Valproic Acid |
| Applicant | MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Contact | Susan D Chew |
| Correspondent | Susan D Chew MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Product Code | LEG |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-11 |
| Decision Date | 1993-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883001305 | K930734 | 000 |