K213718 is an FDA 510(k) clearance for the SOL-GUARD Safety Pull Button Collection Set. This device is classified as a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II - Special Controls, product code JKA).
Submitted by Sol-Millennium Medical, Inc. (Suwanee, US). The FDA issued a Cleared decision on August 30, 2022, 279 days after receiving the submission on November 24, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K213718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2021 |
| Decision Date | August 30, 2022 |
| Days to Decision | 279 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| 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 |