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FDA 510(k) Application Details - K022968
Device Classification Name
Mixture, Hematology Quality Control
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510(K) Number
K022968
Device Name
Mixture, Hematology Quality Control
Applicant
BAYER DIAGNOSTICS CORP.
511 BENEDICT AVE.
TARRYTOWN, NY 10591-5097 US
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Contact
KENNETH T EDDS
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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
09/06/2002
Decision Date
09/24/2002
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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