K780544 is an FDA 510(k) clearance for the DISC-PAK ROTATOR. This device is classified as a Mixer, Blood Tube (Class I - General Controls, product code GLE).
Submitted by Techhnilab Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on April 24, 1978, 21 days after receiving the submission on April 3, 1978.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.2050.
| 510(k) Number | K780544 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1978 |
| Decision Date | April 24, 1978 |
| Days to Decision | 21 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 |