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FDA 510(k) Application Details - K981743
Device Classification Name
Acid Phosphatase, Naphthyl Phosphate
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510(K) Number
K981743
Device Name
Acid Phosphatase, Naphthyl Phosphate
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
862.1020
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Classification Product Code
CKB
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More FDA Info for this Product Code
Date Received
05/18/1998
Decision Date
06/09/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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