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FDA 510(k) Application Details - K113389
Device Classification Name
Urease, Photometric, Urea Nitrogen
More FDA Info for this Device
510(K) Number
K113389
Device Name
Urease, Photometric, Urea Nitrogen
Applicant
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
4 HENDERSON DRIVE
WEST CALDWELL, NJ 07006 US
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Contact
HYMAN KATZ
Other 510(k) Applications for this Contact
Regulation Number
862.1770
More FDA Info for this Regulation Number
Classification Product Code
CDN
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More FDA Info for this Product Code
Date Received
11/16/2011
Decision Date
08/10/2012
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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