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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Coagulation, Automated
510(k) Number K943153
Device Name MICROSAMPLE COAGULATION ANALYZER
Applicant
Bio/Data Corp.
155 Centennial Plz.
Horsham,  PA  19044
Applicant Contact RODNEY W SCARPELLI
Correspondent
Bio/Data Corp.
155 Centennial Plz.
Horsham,  PA  19044
Correspondent Contact RODNEY W SCARPELLI
Regulation Number864.5400
Classification Product Code
GKP  
Date Received06/30/1994
Decision Date 03/24/1995
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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