The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia Dau Ppx/meth Calibrator.
| Device ID | K951153 |
| 510k Number | K951153 |
| Device Name: | CEDIA DAU PPX/METH CALIBRATOR |
| Classification | Calibrators, Drug Specific |
| Applicant | MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Contact | Mary Koning |
| Correspondent | Mary Koning MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Product Code | DLJ |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-14 |
| Decision Date | 1995-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883001992 | K951153 | 000 |
| 00884883001985 | K951153 | 000 |
| 00884883001978 | K951153 | 000 |