K193074 is an FDA 510(k) clearance for the Bevel Up Holder. This device is classified as a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II - Special Controls, product code JKA).
Submitted by Nsp Tech Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on April 21, 2020, 169 days after receiving the submission on November 4, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K193074 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2019 |
| Decision Date | April 21, 2020 |
| Days to Decision | 169 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 |