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FDA 510(k) Application Details - K954437
Device Classification Name
Instrument, Coagulation, Automated
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510(K) Number
K954437
Device Name
Instrument, Coagulation, Automated
Applicant
HAEMOSCOPE CORP.
7855 GROSS POINT RD.
SUITE G4
SKOKIE, IL 60077 US
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Contact
CHARMAINE SUTTON
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Regulation Number
864.5400
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Classification Product Code
GKP
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More FDA Info for this Product Code
Date Received
09/22/1995
Decision Date
01/30/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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