K771523 is an FDA 510(k) clearance for the LATELET RETENTION COLUMN. This device is classified as a Study, Platelet Adhesive (Class II - Special Controls, product code JBZ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on November 22, 1977, 106 days after receiving the submission on August 8, 1977.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6650.
| 510(k) Number | K771523 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 1977 |
| Decision Date | November 22, 1977 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JBZ — Study, Platelet Adhesive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6650 |