CHI · Class I · 21 CFR 862.1465

FDA Product Code CHI: Lipase-esterase, Enzymatic, Photometric, Lipase

Leading manufacturers include Eastman Kodak Company, Wako Chemicals USA, Inc. and Beckman Instruments, Inc..

20
Total
20
Cleared
98d
Avg days
1977
Since

FDA 510(k) Cleared Lipase-esterase, Enzymatic, Photometric, Lipase Devices (Product Code CHI)

20 devices
1–20 of 20
Cleared Jun 04, 1997
SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT
K970905
Beckman Instruments, Inc.
Chemistry · 84d
Cleared Aug 17, 1995
CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS
K952180
Beckman Instruments, Inc.
Chemistry · 100d
Cleared Jul 20, 1995
IL TEST LIPASE
K952647
Instrumentation Laboratory CO
Chemistry · 41d
Cleared May 17, 1994
LIPASE-PS ASSAY PROCEDURE NO. 805
K941085
Sigma Diagnostics, Inc.
Chemistry · 70d
Cleared Jul 21, 1992
WAKO AUTOKIT LIPASE-COLOR
K921249
Wako Chemicals USA, Inc.
Chemistry · 127d
Cleared Mar 11, 1992
MILES LIPASE SERA-PAK METHOD
K920337
Heraeus Kulzer, Inc.
Chemistry · 47d
Cleared May 02, 1990
COLORIMETRIC CHLORIDE PRODUCT #4314125
K900827
American Research Products Co.
Chemistry · 70d
Cleared Dec 06, 1988
ABBOTT A-GENT LIPASE REAGENT
K884596
Abbott Laboratories
Chemistry · 33d
Cleared Feb 24, 1988
KODAK EKTACHEM DT SLIDES (LIPA)
K875173
Eastman Kodak Company
Chemistry · 69d
Cleared Dec 22, 1987
WAKO(TM) AUTOKIT LIPASE
K874640
Wako Chemicals USA, Inc.
Chemistry · 40d
Cleared Jan 18, 1985
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K845027
Eastman Kodak Company
Chemistry · 22d
Cleared Jun 18, 1981
REAGENT SET TRIGLYCERIDES
K811553
Boehringer Mannheim Corp.
Chemistry · 16d

About Product Code CHI - Regulatory Context