K823520 is an FDA 510(k) clearance for the FIBROSYSTEM. This device is classified as a Test, Thromboplastin Generation (Class I - General Controls, product code GKQ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on December 28, 1982, 29 days after receiving the submission on November 29, 1982.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7900.
| 510(k) Number | K823520 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 1982 |
| Decision Date | December 28, 1982 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GKQ — Test, Thromboplastin Generation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.7900 |