K771617 is an FDA 510(k) clearance for the SPECI-MIX. This device is classified as a Mixer, Blood Tube (Class I - General Controls, product code GLE).
Submitted by Thermolyne Corp. (Walker, US). The FDA issued a Cleared decision on September 2, 1977, 9 days after receiving the submission on August 24, 1977.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.2050.
| 510(k) Number | K771617 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 1977 |
| Decision Date | September 02, 1977 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GLE — Mixer, Blood Tube |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2050 |