The following data is part of a premarket notification filed by Quantrx Biomedical Corporation with the FDA for Rapidsense Drugs Of Abuse Methamphetamine (met) 1000 Device, Model 900-0050.
| Device ID | K080455 |
| 510k Number | K080455 |
| Device Name: | RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050 |
| Classification | Gas Chromatography, Methamphetamine |
| 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 | LAF |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-20 |
| Decision Date | 2008-12-31 |
| Summary: | summary |