Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact