FDA 510(k) Application Details - K102419

Device Classification Name	N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin   More FDA Info for this Device
510(K) Number	K102419
Device Name	N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
Applicant	WALLAC OY, SUBSIDIARY OF PERKINELMER 940 WINTER STREET WALTHAM, MA 02451 US Other 510(k) Applications for this Company
Contact	SUSAN K HAMANN Other 510(k) Applications for this Contact
Regulation Number	862.1725   More FDA Info for this Regulation Number
Classification Product Code	JNO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2010
Decision Date	12/16/2010
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