K972969 is an FDA 510(k) clearance for the QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM. This device is classified as a Tube, Collection, Capillary Blood (Class I - General Controls, product code GIO).
Submitted by Innovative Medical Technologies, Inc. (Lenexa, US). The FDA issued a Cleared decision on September 22, 1997, 42 days after receiving the submission on August 11, 1997.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6150.
| 510(k) Number | K972969 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 1997 |
| Decision Date | September 22, 1997 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | GIO - Tube, Collection, Capillary Blood |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.6150 |