The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia Dau Barbiturate Assay.
| Device ID | K945344 |
| 510k Number | K945344 |
| Device Name: | CEDIA DAU BARBITURATE ASSAY |
| Classification | Enzyme Immunoassay, Barbiturate |
| Applicant | MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Contact | Mary Koning |
| Correspondent | Mary Koning MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Product Code | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-01 |
| Decision Date | 1994-12-28 |