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FDA 510(k)

IL TEST IMMUNOGLOBULIN G (IGG)

K-Number: K920006 · 1992-03-13

ApplicantInstrumentation Laboratory CO
Decision Date1992-03-13
Product CodeCGM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IL TEST IMMUNOGLOBULIN G (IGG) is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1992-03-13 under 510(k) number K920006. The device is classified under product code CGM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IL TEST IMMUNOGLOBULIN G (IGG)?

IL TEST IMMUNOGLOBULIN G (IGG) is a medical device that received FDA 510(k) clearance on 1992-03-13. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K920006.

When did IL TEST IMMUNOGLOBULIN G (IGG) receive FDA 510(k) clearance?

IL TEST IMMUNOGLOBULIN G (IGG) received FDA 510(k) clearance on 1992-03-13, under 510(k) number K920006.

Who is the listed applicant for IL TEST IMMUNOGLOBULIN G (IGG)?

The FDA 510(k) record lists Instrumentation Laboratory CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IL TEST IMMUNOGLOBULIN G (IGG)?

The FDA product code for IL TEST IMMUNOGLOBULIN G (IGG) is CGM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Instrumentation Laboratory CO as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223187HemosIL Liquid Anti-XaK223090GEM Premier ChemSTATK223402HemosIL von Willebrand Factor AntigenK213464HemosIL Liquid Anti-XaK213426HemosIL ReadiPlasTin

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Related Devices (Code: CGM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K915650HUMAN IGG SUBCLASS RID KITJanssen BiochimicaK920008IL TEST IMMUNOGLOBULIN M (IGM)Instrumentation Laboratory COK920370ISOTYPES HUMAN IGG SUBCLASS EIA KITIsotypes, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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