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FDA 510(k) Application Details - K021535
Device Classification Name
Calibrator, Secondary
More FDA Info for this Device
510(K) Number
K021535
Device Name
Calibrator, Secondary
Applicant
BAYER DIAGNOSTICS CORP.
511 BENEDICT AVE.
TARRYTOWN, NY 10591-5097 US
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Contact
KENNETH T EDDS
Other 510(k) Applications for this Contact
Regulation Number
862.1150
More FDA Info for this Regulation Number
Classification Product Code
JIT
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More FDA Info for this Product Code
Date Received
05/10/2002
Decision Date
06/27/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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