The following data is part of a premarket notification filed by Microgenics Corporation with the FDA for Cedia Buprenorphine Ii Assay; Cedia Buprenorphine Ii Calibrators; Cedia Negative Calibrator Ii; Cedia Buprenorphine Ii Control Set.
| Device ID | K163101 |
| 510k Number | K163101 |
| Device Name: | CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | MICROGENICS CORPORATION 46500 KATO ROAD Fremont, CA 94538 |
| Contact | Minoti Patel |
| Correspondent | Minoti Patel MICROGENICS CORPORATION 46500 KATO ROAD Fremont, CA 94538 |
| Product Code | DJG |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-07 |
| Decision Date | 2017-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883006065 | K163101 | 000 |
| 00884883006058 | K163101 | 000 |
| 00884883006041 | K163101 | 000 |
| 00884883006034 | K163101 | 000 |
| 00884883004832 | K163101 | 000 |
| 00884883004757 | K163101 | 000 |
| 00884883003873 | K163101 | 000 |
| 00884883003491 | K163101 | 000 |