K010455 is an FDA 510(k) clearance for the ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN. This device is classified as a Assay, Heparin (Class II - Special Controls, product code KFF).
Submitted by Diagnostica-Stago (Parisppany, US). The FDA issued a Cleared decision on June 7, 2001, 129 days after receiving the submission on January 29, 2001.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7525.
| 510(k) Number | K010455 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 2001 |
| Decision Date | June 07, 2001 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | KFF — Assay, Heparin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7525 |