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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Olive Oil Emulsion (Turbidimetric), Lipase
510(k) Number K790796
Device Name LIPASE REAGENT SET
Applicant
ALTA DIAGNOSTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ALTA DIAGNOSTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1465
Classification Product Code
CET  
Date Received04/24/1979
Decision Date 07/17/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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