K913236 is an FDA 510(k) clearance for the STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY. This device is classified as a System, Test, Human Chorionic Gonadotropin (Class II - Special Controls, product code DHA).
Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on August 16, 1991, 25 days after receiving the submission on July 22, 1991.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K913236 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 1991 |
| Decision Date | August 16, 1991 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DHA — System, Test, Human Chorionic Gonadotropin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |