K921636 is an FDA 510(k) clearance for the VACUTAINER(R) BRAND SAFETY-LOK BLOOD COLLECT SET. This device is classified as a Tubes, Vacuum Sample, With Anticoagulant (Class II - Special Controls, product code GIM).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on April 29, 1992, 23 days after receiving the submission on April 6, 1992.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K921636 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 1992 |
| Decision Date | April 29, 1992 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | GIM — Tubes, Vacuum Sample, With Anticoagulant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |