The following data is part of a premarket notification filed by Helmer Labs., Inc. with the FDA for Automated Cell-washing Centrifuge For Immune-hematology.
| Device ID | BK020029 |
| 510k Number | BK020029 |
| Device Name: | Automated Cell-washing Centrifuge For Immune-hematology |
| Classification | Centrifuge, Cell-washing, Automated For Immuno-hematology |
| Applicant | Helmer Labs., Inc. 15425 Herriman Boulevard Noblesville, IN 46060 US |
| Product Code | KSN |
| CFR Regulation Number | 864.9285 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-08 |
| Decision Date | 2002-10-04 |