510(k) K920008

Device: Il Test Immunoglobulin M (igm)
Applicant: INSTRUMENTATION LABORATORY CO.
510(k) number: K920008
Product code: CGM
Decision: Substantially Equivalent (SESE)
Decision date: 1992-03-11
Date received: 1992-01-02
Regulation: 866.5510
Classification name: Method, Immunodiffusion, Immunoglobulins (G, A, M)
Medical specialty: Immunology
Review panel: Immunology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: MURACA, JR.
Address: 113 Hartwell Ave. P.O. Box 9113 Lexington MA US 02173 02173

FDA Registration Numbers#

3019906

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CGM#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K915650	HUMAN IGG SUBCLASS RID KIT	Janssen Biochimica	1992-03-26
K920006	IL TEST IMMUNOGLOBULIN G (IGG)	Instrumentation Laboratory CO	1992-03-13
K920370	ISOTYPES HUMAN IGG SUBCLASS EIA KIT	Isotypes, Inc.	1992-03-11