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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bromcresol Green Dye-Binding, Albumin
510(k) Number K860213
Device Name ALBUMIN 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 Number862.1035
Classification Product Code
CIX  
Date Received01/22/1986
Decision Date 02/11/1986
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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