CHI · Class I · 21 CFR 862.1465

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

Leading manufacturers include Eastman Kodak Company, Beckman Instruments, Inc. and Boehringer Mannheim Corp..

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 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 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