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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bathophenanthroline, Colorimetry, Iron (Non-Heme)
510(k) Number K854305
Device Name DART IRON & IRON BINDING CAPACITY REAGENT
Applicant
COULTER ELECTRONICS, INC.
440 WEST 20 ST.
HIALEAH,  FL  33010
Applicant Contact RICHARD-JONES
Correspondent
COULTER ELECTRONICS, INC.
440 WEST 20 ST.
HIALEAH,  FL  33010
Correspondent Contact RICHARD-JONES
Regulation Number862.1410
Classification Product Code
CFM  
Date Received10/25/1985
Decision Date 11/12/1985
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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