The following data is part of a premarket notification filed by Quantrx Biomedical Corporation with the FDA for Rapidsense Drugs Of Abuse Cocaine (coc) 300 Device, Model 900-0052.
| Device ID | K080436 |
| 510k Number | K080436 |
| Device Name: | RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052 |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | QUANTRX BIOMEDICAL CORPORATION 13721 VIA TRES VISTA San Diego, CA 92129 |
| Contact | Natalie J Kennel |
| Correspondent | Natalie J Kennel QUANTRX BIOMEDICAL CORPORATION 13721 VIA TRES VISTA San Diego, CA 92129 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-19 |
| Decision Date | 2009-02-11 |
| Summary: | summary |