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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 K852636
Device Name X-AMYLASE ASSAY KIT
Applicant
Diagnostic Chemicals, Ltd. (Usa)
16 First St.
West Royalty Industrial Park
Charlottestown,Pei,Canada,  CA C1E 1B0
Applicant Contact CALLBECK R.T.
Correspondent
Diagnostic Chemicals, Ltd. (Usa)
16 First St.
West Royalty Industrial Park
Charlottestown,Pei,Canada,  CA C1E 1B0
Correspondent Contact CALLBECK R.T.
Regulation Number862.1070
Classification Product Code
CIJ  
Date Received06/20/1985
Decision Date 07/12/1985
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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