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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 K961142
Device Name STRATEC LIA II ANALYZER
Applicant
NICHOLS INSTITUTE DIAGNOSTICS
33608 ORTEGA HIGHWAY
SAN JUAN CAPISTRANO,  CA  92690 -6130
Applicant Contact DAVID D SMITH
Correspondent
NICHOLS INSTITUTE DIAGNOSTICS
33608 ORTEGA HIGHWAY
SAN JUAN CAPISTRANO,  CA  92690 -6130
Correspondent Contact DAVID D SMITH
Regulation Number862.2160
Classification Product Code
JJE  
Date Received03/21/1996
Decision Date 02/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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