Submission Details
| 510(k) Number | K213718 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
SOL-GUARD Safety Pull Button Collection Set
Aug 2022
Decision
279d
Days
Class 2
Risk
About This 510(k) Submission
K213718 is an FDA 510(k) clearance for the SOL-GUARD Safety Pull Button Collection Set, 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 review panel. Regulated under 21 CFR 862.1675.
Device Classification
| Product Code | JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1675 |
Manufacturer
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