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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 K861926
Device Name WORTHINGTON HDL PRECIPITATING REAGENT SET
Applicant
Cooper Biomedical, Inc.
One Technology Ct.
Malvern,  PA  19355
Applicant Contact BREWSTER, PHD
Correspondent
Cooper Biomedical, Inc.
One Technology Ct.
Malvern,  PA  19355
Correspondent Contact BREWSTER, PHD
Regulation Number862.1475
Classification Product Code
LBR  
Date Received05/19/1986
Decision Date 06/27/1986
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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