The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia(r) Dau Bar/benz 300,300 Intermed & High Calib.
| Device ID | K936028 |
| 510k Number | K936028 |
| Device Name: | CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB |
| 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 | 1993-12-17 |
| Decision Date | 1994-03-14 |