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FDA 510(k)

ISOTYPES HUMAN IGG SUBCLASS EIA KIT

K-Number: K920370 · 1992-03-11

ApplicantIsotypes, Inc.
Decision Date1992-03-11
Product CodeCGM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ISOTYPES HUMAN IGG SUBCLASS EIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Isotypes, Inc.. It received FDA 510(k) clearance on 1992-03-11 under 510(k) number K920370. 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 ISOTYPES HUMAN IGG SUBCLASS EIA KIT?

ISOTYPES HUMAN IGG SUBCLASS EIA KIT is a medical device that received FDA 510(k) clearance on 1992-03-11. The listed applicant is Isotypes, Inc.. The 510(k) number is K920370.

When did ISOTYPES HUMAN IGG SUBCLASS EIA KIT receive FDA 510(k) clearance?

ISOTYPES HUMAN IGG SUBCLASS EIA KIT received FDA 510(k) clearance on 1992-03-11, under 510(k) number K920370.

Who is the listed applicant for ISOTYPES HUMAN IGG SUBCLASS EIA KIT?

The FDA 510(k) record lists Isotypes, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOTYPES HUMAN IGG SUBCLASS EIA KIT?

The FDA product code for ISOTYPES HUMAN IGG SUBCLASS EIA KIT is CGM.

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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 BiochimicaK920006IL TEST IMMUNOGLOBULIN G (IGG)Instrumentation Laboratory COK920008IL TEST IMMUNOGLOBULIN M (IGM)Instrumentation Laboratory CO

Official Source

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

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