The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Plateletworks, Models Pw-a, Pw-c.
| Device ID | K023761 |
| 510k Number | K023761 |
| Device Name: | PLATELETWORKS, MODELS PW-A, PW-C |
| Classification | System, Automated Platelet Aggregation |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Contact | Patricia Franks |
| Correspondent | Patricia Franks HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Product Code | JOZ |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-08 |
| Decision Date | 2003-02-14 |