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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Hemoglobin, Automated
510(k) Number K020710
Device Name BIOTEST HEMOGLOBIN MEASURING SYSTEM
Applicant
Biotest Medizintechnik GmbH
614 N 4th St.
Richmond,  VA  23219
Applicant Contact MARK LICATA
Correspondent
Biotest Medizintechnik GmbH
614 N 4th St.
Richmond,  VA  23219
Correspondent Contact MARK LICATA
Regulation Number864.5620
Classification Product Code
GKR  
Date Received03/05/2002
Decision Date 08/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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