Submission Details
| 510(k) Number | K910892 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 04, 1991 |
| Decision Date | April 03, 1991 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
K910892 is an FDA 510(k) clearance for the TARGET(TM) CANNABINOIDS-V TEST, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by V-Tech, Inc. (El Monte, US). The FDA issued a Cleared decision on April 3, 1991, 30 days after receiving the submission on March 4, 1991. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K910892 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 04, 1991 |
| Decision Date | April 03, 1991 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LDJ — Enzyme Immunoassay, Cannabinoids |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3870 |