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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K982767
Device Name RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR
Applicant
Raichem
8225 Mercury Court
San Diego,  CA  92129
Applicant Contact MELISSA SANER
Correspondent
Raichem
8225 Mercury Court
San Diego,  CA  92129
Correspondent Contact MELISSA SANER
Regulation Number862.1150
Classification Product Code
JIX  
Subsequent Product Code
LBS  
Date Received08/06/1998
Decision Date 09/21/1998
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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