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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catalytic Methods, Amylase
510(k) Number K951548
Device Name ACE AMYLASE REAGENT
Applicant
Schiapparelli Biosystems, Inc.
9033 Red Branch Rd.
Columbia,  MD  21045
Applicant Contact MARK A SPAIN
Correspondent
Schiapparelli Biosystems, Inc.
9033 Red Branch Rd.
Columbia,  MD  21045
Correspondent Contact MARK A SPAIN
Regulation Number862.1070
Classification Product Code
JFJ  
Date Received04/04/1995
Decision Date 05/15/1995
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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