K883210 is an FDA 510(k) clearance for the EMIT (R) HVA NEGATIVE URINE. This device is classified as a Drug Mixture Control Materials (Class I - General Controls, product code DIF).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on September 19, 1988, 52 days after receiving the submission on July 29, 1988.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K883210 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 1988 |
| Decision Date | September 19, 1988 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DIF — Drug Mixture Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |