K812533 is an FDA 510(k) clearance for the PLATELET AGITATOR. This device is classified as a Device, Blood Mixing And Blood Weighing (Class I - General Controls, product code KSQ).
Submitted by Helmer Labs, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1981, 27 days after receiving the submission on September 2, 1981.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.9195.
| 510(k) Number | K812533 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 1981 |
| Decision Date | September 29, 1981 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KSQ — Device, Blood Mixing And Blood Weighing |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.9195 |