The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Dri Oxycodone Assay.
| Device ID | K040411 |
| 510k Number | K040411 |
| Device Name: | DRI OXYCODONE ASSAY |
| Classification | Drug Specific Control Materials |
| Applicant | MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | David Casal |
| Correspondent | David Casal MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Product Code | LAS |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DLJ |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-18 |
| Decision Date | 2004-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883011625 | K040411 | 000 |
| 07613336154045 | K040411 | 000 |
| 00884883002968 | K040411 | 000 |
| 00884883003477 | K040411 | 000 |
| 00884883005075 | K040411 | 000 |
| 00884883005150 | K040411 | 000 |
| 00884883005167 | K040411 | 000 |
| 00884883005174 | K040411 | 000 |
| 00884883005822 | K040411 | 000 |
| 00884883005884 | K040411 | 000 |
| 00884883005952 | K040411 | 000 |
| 07613336190791 | K040411 | 000 |