The following data is part of a premarket notification filed by Haemonetics Corporation with the FDA for Automated Blood Cell Separators.
| Device ID | BK950033 |
| 510k Number | BK950033 |
| Device Name: | Automated Blood Cell Separators |
| Classification | Separator, Automated, Blood Cell, Diagnostic |
| Applicant | Haemonetics Corporation 400 Wood Road Braintree, MA 02184 |
| Product Code | GKT |
| CFR Regulation Number | 864.9245 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-06 |
| Decision Date | 1996-04-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30812747019341 | BK950033 | 0 |
| 30812747019273 | BK950033 | 0 |
| 30812747019853 | BK950033 | 0 |