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510(k) Data Aggregation
K Number
K020710Device Name
BIOTEST HEMOGLOBIN MEASURING SYSTEM
Manufacturer
Date Cleared
2002-08-14
(162 days)
Product Code
Regulation Number
864.5620Why did this record match?
Applicant Name (Manufacturer) :
BIOTEST MEDIZINTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Biotest Hemoglobin Measuring System is used for quantitative determination of hemoglobin in blood.
Device Description
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