K863491 is an FDA 510(k) clearance for the BLOOD SPECIMEN COLLECTION DEVICES. This device is classified as a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II - Special Controls, product code JKA).
Submitted by Medelec Intl. Corp. (Miami Beach, US). The FDA issued a Cleared decision on October 24, 1986, 46 days after receiving the submission on September 8, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K863491 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 1986 |
| Decision Date | October 24, 1986 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |