K954497 is an FDA 510(k) clearance for the FRONTLINE CANNABIS. This device is classified as a Enzyme Immunoassay, Cannabinoids (Class II - Special Controls, product code LDJ).
Submitted by Boehringer Mannheim Corp. (Rockville, US). The FDA issued a Cleared decision on March 6, 1996, 161 days after receiving the submission on September 27, 1995.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K954497 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 1995 |
| Decision Date | March 06, 1996 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LDJ — Enzyme Immunoassay, Cannabinoids |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |