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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bathophenanthroline, Colorimetry, Iron (Non-Heme)
510(k) Number K810085
Device Name IRON KIT
Applicant
Bio-Analytics Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Bio-Analytics Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1410
Classification Product Code
CFM  
Date Received01/13/1981
Decision Date 01/28/1981
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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