K050878 is an FDA 510(k) clearance for the ON CALL MULTI-DRUG HOME TEST CUP. This device is classified as a Enzyme Immunoassay, Cannabinoids (Class II - Special Controls, product code LDJ).
Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on June 8, 2005, 63 days after receiving the submission on April 6, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K050878 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2005 |
| Decision Date | June 08, 2005 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LDJ — Enzyme Immunoassay, Cannabinoids |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |