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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 K890395
Device Name BIOTROL IRON REAGENT
Applicant
BIOTROL, USA, INC.
113 BRANYWINE PKWY.
WESTCHESTER,  PA  19380
Applicant Contact ALLAN C MURPHY
Correspondent
BIOTROL, USA, INC.
113 BRANYWINE PKWY.
WESTCHESTER,  PA  19380
Correspondent Contact ALLAN C MURPHY
Regulation Number862.1410
Classification Product Code
JIY  
Date Received01/25/1989
Decision Date 03/08/1989
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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