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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 K812533
Device Name PLATELET AGITATOR
Applicant
Helmer Labs, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Helmer Labs, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.9195
Classification Product Code
KSQ  
Date Received09/02/1981
Decision Date 09/29/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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