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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Hematocrit, Automated
510(k) Number K953519
Device Name MICROSPIN 24
Applicant
Vulcon Technologies
718 Main St.
Grandview,  MO  64030
Applicant Contact JEFF HESTAND
Correspondent
Vulcon Technologies
718 Main St.
Grandview,  MO  64030
Correspondent Contact JEFF HESTAND
Regulation Number864.5600
Classification Product Code
GKF  
Date Received07/27/1995
Decision Date 11/03/1995
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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