K912574 is an FDA 510(k) clearance for the ABUSCREEN ONLINE FOR THC (50 AND 100). This device is classified as a Radioimmunoassay, Cannabinoid(s) (Class II - Special Controls, product code LAT).
Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on August 12, 1991, 61 days after receiving the submission on June 12, 1991.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K912574 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 1991 |
| Decision Date | August 12, 1991 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | LAT — Radioimmunoassay, Cannabinoid(s) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |