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FDA 510(k) Application Details - K955752
Device Classification Name
Acid, Uric, Uricase (U.V.)
More FDA Info for this Device
510(K) Number
K955752
Device Name
Acid, Uric, Uricase (U.V.)
Applicant
OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE, NY 11747-3157 US
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Contact
LAURA STORMS-TYLER
Other 510(k) Applications for this Contact
Regulation Number
862.1775
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Classification Product Code
CDO
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More FDA Info for this Product Code
Date Received
12/19/1995
Decision Date
01/31/1996
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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