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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 K892863
Device Name EASY-TEST IRON (IRON) ITEM NO. 16686
Applicant
Em Diagnostic Systems, Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact BENTLEY, PHD
Correspondent
Em Diagnostic Systems, Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact BENTLEY, PHD
Regulation Number862.1410
Classification Product Code
JIY  
Date Received04/18/1989
Decision Date 06/07/1989
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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