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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
Applicant
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD.
W-337
BREA,  CA  92821 -6208
Applicant Contact SHERI HALL
Correspondent
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD.
W-337
BREA,  CA  92821 -6208
Correspondent 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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