K123987 is an FDA 510(k) clearance for the IMPROVE BLOOD COLLECTION SET AND IMPROSAFE 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 Innovative Medical Technologies, Inc. (Leawood, US). The FDA issued a Cleared decision on August 27, 2013, 244 days after receiving the submission on December 26, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K123987 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2012 |
| Decision Date | August 27, 2013 |
| Days to Decision | 244 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | JKA - Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |