The following data is part of a premarket notification filed by Thermo Fisher Scientific with the FDA for Dri Methadone Metabolite (100/300) Assay, Calibrators And Controls.
| Device ID | K081378 |
| 510k Number | K081378 |
| Device Name: | DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS |
| Classification | Enzyme Immunoassay, Methadone |
| Applicant | Thermo Fisher Scientific 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Jack Rogers |
| Correspondent | Jack Rogers Thermo Fisher Scientific 46360 FREMONT BLVD. Fremont, CA 94538 |
| Product Code | DJR |
| Subsequent Product Code | DIF |
| Subsequent Product Code | DKB |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-16 |
| Decision Date | 2009-01-14 |
| Summary: | summary |