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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 K972363
Device Name IL TEST IRON
Applicant
Instrumentation Laboratory CO
113 Hartwell Ave.
Lexington,  MA  02173
Applicant Contact BETTY J LANE
Correspondent
Instrumentation Laboratory CO
113 Hartwell Ave.
Lexington,  MA  02173
Correspondent Contact BETTY J LANE
Regulation Number862.1410
Classification Product Code
JIY  
Date Received06/25/1997
Decision Date 08/15/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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