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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saccharogenic, Amylase
510(k) Number K853951
Device Name ISOTRAK AMYLASE TEST AMYLASE ISOENZYME
Applicant
BEHRING DIAGNOSTICS, INC.
10933 NO TORREY PINES RD.
LA JOLLA,  CA  92037
Applicant Contact JOHN E HUGHES
Correspondent
BEHRING DIAGNOSTICS, INC.
10933 NO TORREY PINES RD.
LA JOLLA,  CA  92037
Correspondent Contact JOHN E HUGHES
Regulation Number862.1070
Classification Product Code
CIJ  
Date Received09/25/1985
Decision Date 01/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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