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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, blood mixing and blood weighing
510(k) Number BK840027
Tradenames Helmer Platelet Agitator PF108, Helmer Platelet Agitator PF54
Device Name Device, Blood Mixing and Weighing
Original Applicant
Helmer Labs., Inc.
5415 distribution drive
fort wayne,  IN  46825
Regulation Number864.9195
Classification Product Code
KSQ  
Date Received10/29/1984
Decision Date 04/16/1985
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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