The following data is part of a premarket notification filed by Medtox Diagnostics, Inc. with the FDA for Sure-screen Amphetamine, Benzodiazepine, Cocaine, Methamphetamine/mdma, Methadone, Opiates, Phencyclidine & Cannabinoids.
| Device ID | K050394 |
| 510k Number | K050394 |
| Device Name: | SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. Burlington, NC 27215 |
| Contact | Alan Morris |
| Correspondent | Alan Morris MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. Burlington, NC 27215 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-16 |
| Decision Date | 2005-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690286000452 | K050394 | 000 |
| 00690286000377 | K050394 | 000 |