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FDA 510(k) Application Details - K033643
Device Classification Name
Calibrator, Secondary
More FDA Info for this Device
510(K) Number
K033643
Device Name
Calibrator, Secondary
Applicant
BAYER HEALTHCARE, DIAGNOSTICS DIVISION
511 BENEDICT AVE.
TARRYTOWN, NY 10591 US
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Contact
KENNETH T EDDS, PH.D.
Other 510(k) Applications for this Contact
Regulation Number
862.1150
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Classification Product Code
JIT
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More FDA Info for this Product Code
Date Received
11/20/2003
Decision Date
01/08/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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