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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name chamber, environmental for the storage of platelet concentrate
510(k) Number BK850015
Tradenames Helmer Incubator Models PC1000, Helmer Incubator Models PC2000, Helmer Incubator Models PC3000
Device Name Chamber, Environmental for the Storage of Platelet Concentrate
Original Applicant
Helmer Labs., Inc.
5415 distribution drive
fort wayne,  IN  46825
Regulation Number864.9575
Classification Product Code
KSH  
Date Received08/12/1985
Decision Date 09/20/1985
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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