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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ferrozine (colorimetric) iron binding capacity
510(k) Number K960485
Device Name SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS
Original Applicant
BECKMAN INSTRUMENTS, INC.
200 south kraemer blvd.
w-337
brea,  CA  92821 -6208
Original Contact sheri hall
Regulation Number862.1415
Classification Product Code
JMO  
Subsequent Product Code
JIT  
Date Received02/02/1996
Decision Date 05/10/1996
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
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