K913399 is an FDA 510(k) clearance for the QBC E-Z PREP. 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 October 18, 1991, 80 days after receiving the submission on July 30, 1991.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K913399 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 1991 |
| Decision Date | October 18, 1991 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |