The following data is part of a premarket notification filed by Haemonetics Corporation with the FDA for Processing Systems For Frozen Blood.
| Device ID | BK060008 |
| 510k Number | BK060008 |
| Device Name: | Processing Systems For Frozen Blood |
| Classification | System, Processing For Frozen Blood |
| Applicant | Haemonetics Corporation 400 Wood Road Braintree, MA 02184 |
| Product Code | KSW |
| CFR Regulation Number | 864.9145 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-02 |
| Decision Date | 2006-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30812747015817 | BK060008 | 0 |
| 30812747015800 | BK060008 | 0 |
| 30812747015183 | BK060008 | 0 |