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FDA 510(k) Application Details - K960471
Device Classification Name
Mixture, Hematology Quality Control
More FDA Info for this Device
510(K) Number
K960471
Device Name
Mixture, Hematology Quality Control
Applicant
HEMATRONIX, INC.
524 STONE RD.
SUITE A
BENICIA, CA 94510 US
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Contact
JAMES D LAPICOLA
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Regulation Number
864.8625
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Classification Product Code
JPK
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More FDA Info for this Product Code
Date Received
02/01/1996
Decision Date
03/20/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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