The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Dri Methadone Metabolite Enzyme Immunoassay.
| Device ID | K023617 |
| 510k Number | K023617 |
| Device Name: | DRI METHADONE METABOLITE ENZYME IMMUNOASSAY |
| Classification | Enzyme Immunoassay, Methadone |
| 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 | DJR |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-29 |
| Decision Date | 2003-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414597584 | K023617 | 000 |
| 00630414595856 | K023617 | 000 |
| 00630414550954 | K023617 | 000 |
| 00630414526904 | K023617 | 000 |
| 00884883012912 | K023617 | 000 |
| 00884883003408 | K023617 | 000 |
| 00884883002920 | K023617 | 000 |