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FDA 510(k) Application Details - K994114
Device Classification Name
Calibrator, Primary
More FDA Info for this Device
510(K) Number
K994114
Device Name
Calibrator, Primary
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
GLASGOW BLDG. 500
NEWARK, DE 19714-6101 US
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Contact
ROBIN O NORRIS
Other 510(k) Applications for this Contact
Regulation Number
862.1150
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Classification Product Code
JIS
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More FDA Info for this Product Code
Date Received
12/06/1999
Decision Date
01/20/2000
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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