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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amyloclastic, Amylase
510(k) Number K844168
Device Name AMYLASE REAGENT CS-726
Applicant
Fisher Scientific Co., LLC
1 Reagent Ln.
Fair Lawn,  NJ  07410
Applicant Contact JACK C MCLAUGHLIN
Correspondent
Fisher Scientific Co., LLC
1 Reagent Ln.
Fair Lawn,  NJ  07410
Correspondent Contact JACK C MCLAUGHLIN
Regulation Number862.1070
Classification Product Code
CJA  
Date Received10/25/1984
Decision Date 11/20/1984
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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