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510(k) K020710

BIOTEST HEMOGLOBIN MEASURING SYSTEM by Biotest Medizintechnik GmbH — Product Code GKR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2002
Date Received
March 5, 2002
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Hemoglobin, Automated
Device Class
Class II
Regulation Number
864.5620
Review Panel
HE
Submission Type

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