K850806 is an FDA 510(k) clearance for the CORNING BLOOD COLLECTION CAPILLARY TUBES. This device is classified as a Tube, Collection, Capillary Blood (Class I - General Controls, product code GIO).
Submitted by Corning Medical & Scientific (Medfield, US). The FDA issued a Cleared decision on March 25, 1985, 26 days after receiving the submission on February 27, 1985.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6150.
| 510(k) Number | K850806 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 1985 |
| Decision Date | March 25, 1985 |
| Days to Decision | 26 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 |