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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lieberman-burchard/abell-kendall, colorimetric, cholesterol
510(k) Number K780545
Device Name SR-PLUS DIRECT CHOLESTEROL TEST
Original Applicant
STANBIO LABORATORY
Regulation Number862.1175
Classification Product Code
CGO  
Date Received04/03/1978
Decision Date 05/26/1978
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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