K122355 is an FDA 510(k) clearance for the VANISHPOINT BLOOD COLLECTION SET. This device is classified as a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II - Special Controls, product code JKA).
Submitted by Retractable Technologies, Inc. (Little Elm, US). The FDA issued a Cleared decision on August 23, 2013, 385 days after receiving the submission on August 3, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K122355 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2012 |
| Decision Date | August 23, 2013 |
| Days to Decision | 385 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| 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 |