The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia(r) Tobramycin Assay.
| Device ID | K912143 |
| 510k Number | K912143 |
| Device Name: | CEDIA(R) TOBRAMYCIN ASSAY |
| Classification | Fluorescence Polarization Immunoassay, Tobramycin |
| 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 | LFW |
| CFR Regulation Number | 862.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-15 |
| Decision Date | 1991-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883005631 | K912143 | 000 |