K073078 is an FDA 510(k) clearance for the RAPID TOX CUP. This device is classified as a High Pressure Liquid Chromatography, Methamphetamine (Class II - Special Controls, product code LAG).
Submitted by American Bio Medica Corp. (Logan Township, US). The FDA issued a Cleared decision on May 30, 2008, 212 days after receiving the submission on October 31, 2007.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3610.
| 510(k) Number | K073078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2007 |
| Decision Date | May 30, 2008 |
| Days to Decision | 212 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LAG — High Pressure Liquid Chromatography, Methamphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3610 |