K945952 is an FDA 510(k) clearance for the VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE. This device is classified as a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II - Special Controls, product code JKA).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on January 18, 1995, 43 days after receiving the submission on December 6, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K945952 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 1994 |
| Decision Date | January 18, 1995 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |