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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 K935712
Device Name IRON/TIBC REAGENT
Applicant
Horizon Diagnostics, Inc.
3660 Plz. Dr.,Suite 4
Ann Arbor,  MI  48108
Applicant Contact DAVID CALLENDER
Correspondent
Horizon Diagnostics, Inc.
3660 Plz. Dr.,Suite 4
Ann Arbor,  MI  48108
Correspondent Contact DAVID CALLENDER
Regulation Number862.1410
Classification Product Code
JIY  
Subsequent Product Code
JMO  
Date Received11/30/1993
Decision Date 09/20/1995
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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