The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia Dau Methadone Assay.
| Device ID | K954227 |
| 510k Number | K954227 |
| Device Name: | CEDIA DAU METHADONE ASSAY |
| Classification | Enzyme Immunoassay, Methadone |
| Applicant | MICROGENICS CORP. 2400 BISSO LN. P.O. BOX 4117 Concord, CA 94524 -4117 |
| Contact | Mary Koning |
| Correspondent | Mary Koning MICROGENICS CORP. 2400 BISSO LN. P.O. BOX 4117 Concord, CA 94524 -4117 |
| Product Code | DJR |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-11 |
| Decision Date | 1995-11-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883012547 | K954227 | 000 |
| 00884883004313 | K954227 | 000 |
| 00884883001503 | K954227 | 000 |
| 00884883001442 | K954227 | 000 |