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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 K831201
Device Name SERUM IRON-PTF-600
Applicant
AMERICAN MONITOR CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERICAN MONITOR CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1410
Classification Product Code
JIY  
Date Received04/13/1983
Decision Date 05/25/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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