FDA 510(k) Application Details - K960485

Device Classification Name Ferrozine (Colorimetric) Iron Binding Capacity

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510(K) Number K960485
Device Name Ferrozine (Colorimetric) Iron Binding Capacity
Applicant BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD.
W-337
BREA, CA 92821-6208 US
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Contact SHERI HALL
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Regulation Number 862.1415

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Classification Product Code JMO
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Date Received 02/02/1996
Decision Date 05/10/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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