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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photometric Method, Iron (Non-Heme)
510(k) Number K841887
Device Name PARAMAX IRON BLANK REAGENT
Applicant
AMERICAN DADE
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERICAN DADE
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1410
Classification Product Code
JIY  
Date Received05/07/1984
Decision Date 06/22/1984
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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