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FDA 510(k) Application Details - K955139
Device Classification Name
Ferrozine (Colorimetric) Iron Binding Capacity
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510(K) Number
K955139
Device Name
Ferrozine (Colorimetric) Iron Binding Capacity
Applicant
OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE, NY 11747-3157 US
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Contact
LAURA STORMS-TYLER
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Regulation Number
862.1415
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Classification Product Code
JMO
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More FDA Info for this Product Code
Date Received
11/13/1995
Decision Date
02/12/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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