The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia(r) Theophylline Assay/modification.
| Device ID | K905521 |
| 510k Number | K905521 |
| Device Name: | CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION |
| Classification | Fluorescent Immunoassay, Theophylline |
| Applicant | MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Contact | Patricia M Klimley |
| Correspondent | Patricia M Klimley MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Product Code | LER |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-07 |
| Decision Date | 1990-12-26 |