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FDA 510(k) Application Details - K110274
Device Classification Name
N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
More FDA Info for this Device
510(K) Number
K110274
Device Name
N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
Applicant
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC.
940 WINTER STREET
WALTHAM, MA 02451 US
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Contact
SUSAN K HAMANN
Other 510(k) Applications for this Contact
Regulation Number
862.1725
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Classification Product Code
JNO
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More FDA Info for this Product Code
Date Received
01/31/2011
Decision Date
06/10/2011
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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