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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 K791922
Device Name HARLECO BRAND CLINICARD LIPASE TEST SET
Applicant
DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1465
Classification Product Code
CET  
Date Received09/26/1979
Decision Date 11/27/1979
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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