The following data is part of a premarket notification filed by Helmer Labs., Inc. with the FDA for Blood Mixing And Weighing Devices.
| Device ID | BK820013 |
| 510k Number | BK820013 |
| Device Name: | Blood Mixing And Weighing Devices |
| Classification | Device, Blood Mixing And Blood Weighing |
| Applicant | Helmer Labs., Inc. 5415 Distribution Drive Fort Wayne, IN 46825 |
| Product Code | KSQ |
| CFR Regulation Number | 864.9195 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-01 |
| Decision Date | 1982-10-29 |