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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
510(k) Number K021671
Device Name JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
Applicant
Jas Diagnostics, Inc.
7220 NW 58th St.
Miami,  FL  33166
Applicant Contact David Johnston
Correspondent
Jas Diagnostics, Inc.
7220 NW 58th St.
Miami,  FL  33166
Correspondent Contact David Johnston
Regulation Number862.1475
Classification Product Code
LBS  
Subsequent Product Codes
JIX   JJY  
Date Received05/21/2002
Decision Date 07/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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