K893577 is an FDA 510(k) clearance for the STATUS HCG FLUOROMETRIC ENZYME. 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 3, 1989, 86 days after receiving the submission on May 9, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K893577 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 1989 |
| Decision Date | August 03, 1989 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DHA — System, Test, Human Chorionic Gonadotropin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |