The following data is part of a premarket notification filed by Medtox Diagnostics, Inc. with the FDA for Medtox Buprenorphine Test.
| Device ID | K100951 |
| 510k Number | K100951 |
| Device Name: | MEDTOX BUPRENORPHINE TEST |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. Burlington, NC 27215 |
| Contact | Phillip Hartzog |
| Correspondent | Phillip Hartzog MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. Burlington, NC 27215 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-06 |
| Decision Date | 2010-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10690286000541 | K100951 | 000 |