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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, chemistry (photometric, discrete), for clinical use
510(k) Number K003721
Device Name MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
Applicant
OLYMPUS AMERICA, INC.
3131 WEST ROYAL LN.
IRVING,  TX  75063 -3104
Applicant Contact MICHAEL CAMPBELL
Correspondent
OLYMPUS AMERICA, INC.
3131 WEST ROYAL LN.
IRVING,  TX  75063 -3104
Correspondent Contact MICHAEL CAMPBELL
Regulation Number862.2160
Classification Product Code
JJE  
Subsequent Product Codes
CDQ   CEK   CEO   CFJ   CFR  
CGX   CHS   CIC   CIG   CIT   CIX  
CJK   CJY   JFS   JGS   JHW   JJX  
KHM  
Date Received12/04/2000
Decision Date 12/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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