The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Thermo Scientific Cedia Opiate Oft Assay.
| Device ID | K101754 |
| 510k Number | K101754 |
| Device Name: | THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | MICROGENICS CORP. 46360 FREMONT BLVD Fremont, CA 94538 |
| Contact | Lisa Charter |
| Correspondent | Lisa Charter MICROGENICS CORP. 46360 FREMONT BLVD Fremont, CA 94538 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-22 |
| Decision Date | 2011-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883011113 | K101754 | 000 |
| 00884883000810 | K101754 | 000 |
| 00884883000247 | K101754 | 000 |