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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameOlympus AU 600  {Sigma Diagnostics EZ HDL Cholesterol} 
Document NumberK963847
Parent Document NumberK963847
Analyte NameHDL cholesterol
Analyte SpecialtyGeneral Chemistry
ComplexityMODERATE
Effective Date05/16/1997
Device Classification Name Calibrator, Primary
510(k) Number K963847
Device Name WAKO DIRECT HDL-C
Applicant
Wako Chemicals USA, Inc.
1600 Bellwood Rd.
Richmond,  VA  23237
Applicant Contact TONYA MALLORY
Correspondent
Wako Chemicals USA, Inc.
1600 Bellwood Rd.
Richmond,  VA  23237
Correspondent Contact TONYA MALLORY
Regulation Number862.1150
Classification Product Code
JIS  
Subsequent Product Code
LBR  
Date Received09/25/1996
Decision Date 12/24/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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