Product Code: CFP FDA class 1 21 CFR 862.1405

Radioimmunoassay, Immunoreactive Insulin

Clinical Chemistry

The Radioimmunoassay, Immunoreactive Insulin test system (product code CFP) is an in-vitro diagnostic device used in clinical chemistry to measure immunoreactive insulin levels in blood or serum using a radioimmunoassay technique. It is classified as FDA Class 1, the lowest risk tier, subject only to general controls and not requiring premarket notification. It falls under regulation 21 CFR 862.1405 in the Clinical Chemistry medical specialty.

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FEI Numbers

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Basic Information

Product Code: CFP
Device Class: FDA class 1
Regulation Number: 862.1405
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K963911	ALPCO/MERCODIA INSULIN ELISA	Nov 01, 1996	Substantially Equivalent	American Laboratory Products Co., Ltd.
K953084	ACCESS ULTRASENSITIVE INSULIN ASSAY	Sep 25, 1995	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K920109	IMX INSULIN	May 07, 1992	Substantially Equivalent	Abbott Laboratories
K914820	DSL INSULIN RIA (DSL 1600)	Jan 09, 1992	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K903628	AIA-PACK IRI	Sep 07, 1990	Substantially Equivalent	Tosoh Corp.
K901135	ENZYMUN TEST(R) INSULIN	Apr 03, 1990	Substantially Equivalent	Boehringer Mannheim Corp.
K896572	REP(TM) SPE PLUS-30 PROCEDURES	Jan 11, 1990	Substantially Equivalent	Helena Laboratories
K890837	RIA-GNOST INSULIN	Apr 26, 1989	Substantially Equivalent	Cambridge Medical Technology
K851071	PHARMACIA INSULIN RIA	Apr 12, 1985	Substantially Equivalent	Pharmacia, Inc.
K841573	INSULIN RADIOIMMUNOASSAY KIT	May 16, 1984	Substantially Equivalent	Sorin Biomedica, Fiat, USA, Inc.
K823939	WAKO INSULIN TEST	Jan 28, 1983	Substantially Equivalent	Wako Chemicals USA, Inc.
K822509	COVALENT COAT RIA KIT	Sep 28, 1982	Substantially Equivalent	Immuchem Corp.
K821861	COAT-A-COUNT INSULIN KIT	Jul 08, 1982	Substantially Equivalent	Diagnostic Products Corp.
K821374	ENZYMUNE-TEST INSULIN	May 28, 1982	Substantially Equivalent	Icl Scientific
K812227	GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY	Sep 24, 1981	Substantially Equivalent	Clinical Assays, Inc.
K811953	IMMOPHASE INSULIN (125I) RADIOASSAY	Jul 23, 1981	Substantially Equivalent	Corning Medical & Scientific
K811423	VENTRE/SEP	Jun 09, 1981	Substantially Equivalent	Ventrex Laboratories, Inc.
K811144	ARIA II INSULIN RIA	May 15, 1981	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K792279	AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM	Dec 06, 1979	Substantially Equivalent	Micromedic Systems
K791707	CENTRIA INSULIN RIA	Oct 17, 1979	Substantially Equivalent	Ventrex Laboratories, Inc.
K790630	RIA, INSULIN, DOUBLE ANTIBODY	Jul 24, 1979	Substantially Equivalent	Endocrine-Metabolic Center
K781285	INSULIN RIA KIT	Aug 14, 1978	Substantially Equivalent	Serono Laboratories, Inc.
K781086	INSULIN AUTOPAK	Aug 14, 1978	Substantially Equivalent	Micromedic Systems
K771947	INSULIN RIA MODULE	Jan 20, 1978	Substantially Equivalent	Inter Science Institute
K772281	RSL INSULIN KIT	Jan 06, 1978	Substantially Equivalent	Radioassay Systems Laboratories, Inc.
K771979	CENTRIA INSULIN RIA	Nov 17, 1977	Substantially Equivalent	Union Carbide Corp.
K771628	NSULIN RIA KIT 125I	Sep 20, 1977	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic