CET · Class I · 21 CFR 862.1465

FDA Product Code CET: Olive Oil Emulsion (turbidimetric), Lipase

Leading manufacturers include E.I. Dupont DE Nemours & Co., Inc., Dade, Baxter Travenol Diagnostics, Inc. and Mallinckrodt Critical Care.

15
Total
15
Cleared
77d
Avg days
1977
Since

FDA 510(k) Cleared Olive Oil Emulsion (turbidimetric), Lipase Devices (Product Code CET)

15 devices
1–15 of 15
Cleared Mar 06, 1997
LIPASE REAGENT SET (COLIPASE METHOD)
K970124
Teco Diagnostics
Chemistry · 51d
Cleared Jun 02, 1994
LIPASE REAGENT SYSTEM
K940457
Medical Diagnostic Technologies, Inc.
Chemistry · 121d
Cleared Jun 12, 1990
MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST
K901858
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 49d
Cleared Mar 13, 1989
LIPASE SR LIQUID STABLE REAGENT SET
K885078
Medical Analysis Systems, Inc.
Chemistry · 95d
Cleared Mar 12, 1987
BECKMAN EPSILON(TM) LIPASE TEST KIT
K864438
Beckman Instruments, Inc.
Chemistry · 120d
Cleared Aug 04, 1986
PARAMAX LIPASE REAGENT
K862440
American Dade
Chemistry · 39d
Cleared Feb 12, 1985
ENZYGNOST LIPASE TEST
K844240
Behring Diagnostics, Inc.
Chemistry · 103d
Cleared Apr 18, 1983
NUCLIPASE (I125) PANCREATIC LIPASE
K823860
Nuclear Diagnostics, Inc.
Chemistry · 117d
Cleared Oct 20, 1981
LIPASE
K812794
Pointe Scientific, Inc.,
Chemistry · 14d
Cleared Dec 18, 1979
LIPASE TEST KIT
K792289
Mallinckrodt Critical Care
Chemistry · 35d
Cleared Nov 27, 1979
HARLECO BRAND CLINICARD LIPASE TEST SET
K791922
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 62d
Cleared Apr 15, 1977
ACA LIPASE ANALYTICAL TEST PACK
K770364
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 51d

About Product Code CET - Regulatory Context