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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid Phosphatase, Naphthyl Phosphate
510(k) Number K981743
Device Name OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER
Applicant
OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Applicant Contact LAURA STORMS-TYLER
Correspondent
OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Correspondent Contact LAURA STORMS-TYLER
Regulation Number862.1020
Classification Product Code
CKB  
Subsequent Product Codes
CDO   CDQ   CEO   CFQ   CFR  
CGS   CGX   CHH   CHJ   CIC   CIG  
CIT   CIX   CJE   CZW   DCN   DEF  
DGI   DHR   DOD   JFJ   JGJ   JGS  
JHN   JIY   JJE   JLB   JMO  
Date Received05/18/1998
Decision Date 06/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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