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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 K935287
Device Name IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM
Applicant
Miles, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact GABRIEL J MURACA
Correspondent
Miles, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact GABRIEL J MURACA
Regulation Number862.1410
Classification Product Code
JIY  
Date Received11/03/1993
Decision Date 01/03/1994
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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