Product Code: CHI FDA class 1 21 CFR 862.1465

Lipase-Esterase, Enzymatic, Photometric, Lipase

Clinical Chemistry

The Lipase-Esterase, Enzymatic, Photometric, Lipase test system (product code CHI) is an in-vitro diagnostic device used in clinical chemistry to measure lipase enzyme activity in serum or plasma using an enzymatic lipase-esterase photometric assay, supporting the diagnosis of pancreatitis and other pancreatic disorders. It is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. It falls under regulation 21 CFR 862.1465 in the Clinical Chemistry medical specialty.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code CHI in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: CHI
Device Class: FDA class 1
Regulation Number: 862.1465
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 20 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K970905	SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT	Jun 04, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K961179	SENTINEL LIPASE LIQUID MODEL 17.401B	Jul 19, 1996	Substantially Equivalent	Equal Diagnostics, Inc.
K952180	CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS	Aug 17, 1995	Substantially Equivalent	Beckman Instruments, Inc.
K952816	LIPASE FLEX REAGENT CARTRIDGE	Jul 20, 1995	Substantially Equivalent	Dupont Medical Products
K952647	IL TEST LIPASE	Jul 20, 1995	Substantially Equivalent	Instrumentation Laboratory CO
K941085	LIPASE-PS ASSAY PROCEDURE NO. 805	May 17, 1994	Substantially Equivalent	Sigma Diagnostics, Inc.
K923917	ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY	Feb 25, 1994	Substantially Equivalent	Nuclear Diagnostics, Inc.
K921249	WAKO AUTOKIT LIPASE-COLOR	Jul 21, 1992	Substantially Equivalent	Wako Chemicals USA, Inc.
K920337	MILES LIPASE SERA-PAK METHOD	Mar 11, 1992	Substantially Equivalent	Heraeus Kulzer, Inc.
K900827	COLORIMETRIC CHLORIDE PRODUCT #4314125	May 02, 1990	Substantially Equivalent	American Research Products Co.
K897150	LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT	Feb 26, 1990	Substantially Equivalent	Toyo Jozo Co., Ltd.
K884596	ABBOTT A-GENT LIPASE REAGENT	Dec 06, 1988	Substantially Equivalent	Abbott Laboratories
K874027	LIPASE UV [TOYO]	May 27, 1988	Substantially Equivalent	Advocacy International, Ltd.
K875173	KODAK EKTACHEM DT SLIDES (LIPA)	Feb 24, 1988	Substantially Equivalent	Eastman Kodak Company
K874640	WAKO(TM) AUTOKIT LIPASE	Dec 22, 1987	Substantially Equivalent	Wako Chemicals USA, Inc.
K862312	ENZLIPASE, ENZYMATIC LIPASE KIT	Sep 26, 1986	Substantially Equivalent	Nuclear Diagnostics, Inc.
K845027	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES	Jan 18, 1985	Substantially Equivalent	Eastman Kodak Company
K811553	REAGENT SET TRIGLYCERIDES	Jun 18, 1981	Substantially Equivalent	Boehringer Mannheim Corp.
K802842	SINGLE VIAL LIPASE TEST KIT	Dec 18, 1980	Substantially Equivalent	Biodynamics Corp.
K760786	ENZYMATIC LIPASE MAX-PACK REAGENT	Jan 06, 1977	Substantially Equivalent	Calbiochem