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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo, Ast/Sgot
510(k) Number K821209
Device Name SGOT REAGENT SET
Applicant
Omega Medical Electronics
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Omega Medical Electronics
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1100
Classification Product Code
CIQ  
Date Received04/27/1982
Decision Date 07/14/1982
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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