The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Plateletworks.
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PLATELETWORKS 75471157 2487999 Live/Registered |
HELENA LABORATORIES CORPORATION 1998-04-21 |