The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia Dau Negative Calibrator.
| Device ID | K935793 |
| 510k Number | K935793 |
| Device Name: | CEDIA DAU NEGATIVE CALIBRATOR |
| Classification | Calibrators, Drug Mixture |
| Applicant | MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Contact | Betsy Soares-maddox |
| Correspondent | Betsy Soares-maddox MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-07 |
| Decision Date | 1994-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883011489 | K935793 | 000 |
| 00884883001961 | K935793 | 000 |