The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Dri Cotinine Eia Assay.
| Device ID | K030649 |
| 510k Number | K030649 |
| Device Name: | DRI COTININE EIA ASSAY |
| Classification | Test System, Nicotine, Cotinine, Metabolites |
| Applicant | MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Lakshmi Anne |
| Correspondent | Lakshmi Anne MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Product Code | MRS |
| CFR Regulation Number | 862.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-28 |
| Decision Date | 2003-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883012905 | K030649 | 000 |
| 00884883002876 | K030649 | 000 |
| 00884883001084 | K030649 | 000 |
| 00884883001077 | K030649 | 000 |
| 00884883001060 | K030649 | 000 |
| 00884883001053 | K030649 | 000 |