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FDA 510(k) Application Details - K123322
Device Classification Name
Urease, Photometric, Urea Nitrogen
More FDA Info for this Device
510(K) Number
K123322
Device Name
Urease, Photometric, Urea Nitrogen
Applicant
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC
4 HENDERSON DRIVE
WEST CALDWELL, NJ 07006 US
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Contact
HYMAN KATZ PH.D.
Other 510(k) Applications for this Contact
Regulation Number
862.1770
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Classification Product Code
CDN
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More FDA Info for this Product Code
Date Received
10/26/2012
Decision Date
05/21/2013
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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