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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
510(k) Number K790791
Device Name ELECTROPHORESIS REAGENT SET, HDL
Applicant
Gelman Sciences, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Gelman Sciences, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1475
Classification Product Code
LBT  
Date Received04/24/1979
Decision Date 06/15/1979
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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