Il Test Immunoglobulin M (Igm)

FDA 510(k) K920008 · Instrumentation Laboratory CO

Substantially Equivalent

510(k) numberK920008

Submission

Device name
Il Test Immunoglobulin M (Igm)
Applicant
Instrumentation Laboratory CO
Lexington, MA, US
Received
January 2, 1992
Decision date
March 11, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CGM – Method, Immunodiffusion, Immunoglobulins (G, A, M)
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5510
Specialty
Immunology

Other 510(k)s with product code CGM

510(k)DeviceApplicantDecision
K915650Human Igg Subclass Rid KitCGM · Traditional Janssen Biochimica03/26/1992SE
K920006Il Test Immunoglobulin G (Igg)CGM · Traditional Instrumentation Laboratory CO03/13/1992SE
K920370Isotypes Human Igg Subclass Eia KitCGM · Traditional Isotypes, Inc.03/11/1992SE

More from Isotypes, Inc.

510(k)DeviceDecision
K233790Acl Top 970 CLJPA · Special 12/29/2023SE
K230852HemosIL Chromogenic Factor IXGGP · Traditional 12/13/2023SE
K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA · Traditional 09/29/2023SE
K223608GEM Premier 7000 with IQM3CHL · Traditional 08/10/2023SE
K223187HemosIL Liquid Anti-XaQLU · Traditional 06/23/2023SE
K231031ACL TOP Family 70 SeriesGKP · Traditional 06/21/2023SE
K223090GEM Premier ChemSTATCGA · Special 01/27/2023SE
K223402HemosIL von Willebrand Factor AntigenGGP · Special 12/09/2022SE
K213464HemosIL Liquid Anti-XaKFF · Special 10/04/2022SE
K213426HemosIL ReadiPlasTinGJS · Traditional 08/16/2022SE

Questions and answers

When was Il Test Immunoglobulin M (Igm) cleared by the FDA?

Il Test Immunoglobulin M (Igm) (K920008) received a 510(k) decision of Substantially Equivalent on March 11, 1992, 69 days after the submission was received.

What is the product code of K920008?

The FDA product code is CGM – Method, Immunodiffusion, Immunoglobulins (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.