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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Starch-Dye Bound Polymer, Amylase
510(k) Number K850639
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
Correspondent
Bio-Analytics Laboratories, Inc.
One Bio-Analytics Pl.
Box 333
Palm City,  FL  33490
Correspondent Contact ROY
Regulation Number862.1070
Classification Product Code
CIW  
Date Received02/19/1985
Decision Date 03/05/1985
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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