K823124 is an FDA 510(k) clearance for the IMS HEMATOLOGY MIXER. This device is classified as a Mixer, Blood Tube (Class I - General Controls, product code GLE).
Submitted by Innovative Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1982, 31 days after receiving the submission on October 22, 1982.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.2050.
| 510(k) Number | K823124 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 1982 |
| Decision Date | November 22, 1982 |
| Days to Decision | 31 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 |