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 IDK012723
510k NumberK012723
Device Name:PLATELETWORKS
ClassificationSystem, Automated Platelet Aggregation
Applicant HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont,  TX  77704
ContactPatricia Franks
CorrespondentPatricia Franks
HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont,  TX  77704
Product CodeJOZ  
CFR Regulation Number864.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-15
Decision Date2001-09-28

Trademark Results [PLATELETWORKS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PLATELETWORKS
PLATELETWORKS
75471157 2487999 Live/Registered
HELENA LABORATORIES CORPORATION
1998-04-21

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