K884623 is an FDA 510(k) clearance for the SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE. This device is classified as a Tube, Collection, Capillary Blood (Class I - General Controls, product code GIO).
Submitted by Safe-Tec Clinical Products, Inc. (Ivyland, US). The FDA issued a Cleared decision on December 1, 1988, 27 days after receiving the submission on November 4, 1988.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6150.
| 510(k) Number | K884623 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 1988 |
| Decision Date | December 01, 1988 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GIO — Tube, Collection, Capillary Blood |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.6150 |