FDA 510(k) Applications for Medical Device Product Code "CET"
(Olive Oil Emulsion (Turbidimetric), Lipase)

FDA 510(k) Number Applicant Device Name Decision Date
K790796 ALTA DIAGNOSTICS, INC. LIPASE REAGENT SET 07/17/1979
K862440 AMERICAN DADE PARAMAX LIPASE REAGENT 08/04/1986
K864438 BECKMAN INSTRUMENTS, INC. BECKMAN EPSILON(TM) LIPASE TEST KIT 03/12/1987
K844240 BEHRING DIAGNOSTICS, INC. ENZYGNOST LIPASE TEST 02/12/1985
K791922 DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. HARLECO BRAND CLINICARD LIPASE TEST SET 11/27/1979
K770364 E.I. DUPONT DE NEMOURS & CO., INC. "ACA" LIPASE ANALYTICAL TEST PACK 04/15/1977
K901858 E.I. DUPONT DE NEMOURS & CO., INC. MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST 06/12/1990
K893718 ELECTRO-NUCLEONICS, INC. DELTATEST (R) LIPASE II 09/28/1989
K792289 MALLINCKRODT CRITICAL CARE LIPASE TEST KIT 12/18/1979
K885078 MEDICAL ANALYSIS SYSTEMS, INC. LIPASE SR LIQUID STABLE REAGENT SET 03/13/1989
K940457 MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. LIPASE REAGENT SYSTEM 06/02/1994
K823860 NUCLEAR DIAGNOSTICS, INC. NUCLIPASE (I125) PANCREATIC LIPASE 04/18/1983
K812794 POINTE SCIENTIFIC, INC. LIPASE 10/20/1981
K915706 TECH INTL. CO. LIPASE REAGENT SET 02/18/1992
K970124 TECO DIAGNOSTICS LIPASE REAGENT SET (COLIPASE METHOD) 03/06/1997


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