K833891 is an FDA 510(k) clearance for the COATEST HEPARIN. This device is classified as a Assay, Heparin (Class II - Special Controls, product code KFF).
Submitted by Kabivitrum, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984, 82 days after receiving the submission on November 9, 1983.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7525.
| 510(k) Number | K833891 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 1983 |
| Decision Date | January 30, 1984 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KFF — Assay, Heparin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7525 |