PLATELETWORKS
System, Automated Platelet Aggregation
HELENA LABORATORIES
The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Plateletworks.
Pre-market Notification Details
| Device ID | K012723 |
| 510k Number | K012723 |
| Device Name: | PLATELETWORKS |
| 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 | 2001-08-15 |
| Decision Date | 2001-09-28 |
Trademark Results [PLATELETWORKS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PLATELETWORKS 75471157 2487999 Live/Registered |
HELENA LABORATORIES CORPORATION 1998-04-21 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.