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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 K860245
Device Name ENZYMATIC ALPHA-AMYLASE REAGENT KIT
Applicant
Bio-Analytics Laboratories, Inc.
One Bio-Analytics Pl.
Box 333
Palm City,  FL  33490
Applicant Contact ROY, PH.D.
Correspondent
Bio-Analytics Laboratories, Inc.
One Bio-Analytics Pl.
Box 333
Palm City,  FL  33490
Correspondent Contact ROY, PH.D.
Regulation Number862.1070
Classification Product Code
JFJ  
Date Received01/24/1986
Decision Date 03/14/1986
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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