K874757 is an FDA 510(k) clearance for the STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III. This device is classified as a Drug Mixture Control Materials (Class I - General Controls, product code DIF).
Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on February 2, 1988, 76 days after receiving the submission on November 18, 1987.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K874757 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1987 |
| Decision Date | February 02, 1988 |
| Days to Decision | 76 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 |