K820773 is an FDA 510(k) clearance for the EMIT-ST URINE COCAINE METABOLITE ASSAY. This device is classified as a Bacillus Subtilis Microbiology Assay, Tobramycin (Class II - Special Controls, product code DID).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on April 8, 1982, 16 days after receiving the submission on March 23, 1982.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3900.
| 510(k) Number | K820773 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 1982 |
| Decision Date | April 08, 1982 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DID — Bacillus Subtilis Microbiology Assay, Tobramycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3900 |