K914901 is an FDA 510(k) clearance for the VACUTAINER KIT. This device is classified as a Tubes, Vacuum Sample, With Anticoagulant (Class II - Special Controls, product code GIM).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 8, 1992, 68 days after receiving the submission on November 1, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K914901 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 1991 |
| Decision Date | January 08, 1992 |
| Days to Decision | 68 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 |