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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, Hdl
510(k) Number K895381
Device Name HDL SINGLES
Applicant
Trace America, Inc.
7260 NW 58th St.
Miami,  FL  33166
Applicant Contact David Johnston
Correspondent
Trace America, Inc.
7260 NW 58th St.
Miami,  FL  33166
Correspondent Contact David Johnston
Regulation Number862.1475
Classification Product Code
LBR  
Date Received08/29/1989
Decision Date 11/08/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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