The following data is part of a premarket notification filed by Helmer Labs, Inc. with the FDA for Platelet Agitator.
| Device ID | K812533 |
| 510k Number | K812533 |
| Device Name: | PLATELET AGITATOR |
| Classification | Device, Blood Mixing And Blood Weighing |
| Applicant | HELMER LABS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KSQ |
| CFR Regulation Number | 864.9195 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-02 |
| Decision Date | 1981-09-29 |