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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wright'S Stain
510(k) Number K792497
Device Name VOLU-SOL STATIM STAIN
Applicant
Volu Sol Medical Industries
MD 
Correspondent
Volu Sol Medical Industries
MD 
Regulation Number864.1850
Classification Product Code
IAF  
Date Received12/04/1979
Decision Date 12/18/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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