K781303 is an FDA 510(k) clearance for the BIO-PRO UNIT. This device is classified as a Subsystem, Proportioning (Class II - Special Controls, product code FKR).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on October 2, 1978, 67 days after receiving the submission on July 27, 1978.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K781303 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 1978 |
| Decision Date | October 02, 1978 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | FKR — Subsystem, Proportioning |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |