K990377 is an FDA 510(k) clearance for the ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV. This device is classified as a Drug Mixture Control Materials (Class I - General Controls, product code DIF).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on February 26, 1999, 18 days after receiving the submission on February 8, 1999.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K990377 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 1999 |
| Decision Date | February 26, 1999 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DIF — Drug Mixture Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |