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FDA 510(k)

HUMAN IGG SUBCLASS RID KIT

K-Number: K915650 · 1992-03-26

ApplicantJanssen Biochimica
Decision Date1992-03-26
Product CodeCGM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HUMAN IGG SUBCLASS RID KIT is the device name listed in this FDA 510(k) record. The listed applicant is Janssen Biochimica. It received FDA 510(k) clearance on 1992-03-26 under 510(k) number K915650. 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 HUMAN IGG SUBCLASS RID KIT?

HUMAN IGG SUBCLASS RID KIT is a medical device that received FDA 510(k) clearance on 1992-03-26. The listed applicant is Janssen Biochimica. The 510(k) number is K915650.

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

HUMAN IGG SUBCLASS RID KIT received FDA 510(k) clearance on 1992-03-26, under 510(k) number K915650.

Who is the listed applicant for HUMAN IGG SUBCLASS RID KIT?

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

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

The FDA product code for HUMAN IGG SUBCLASS RID 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.

K920006IL TEST IMMUNOGLOBULIN G (IGG)Instrumentation Laboratory COK920008IL TEST IMMUNOGLOBULIN M (IGM)Instrumentation Laboratory COK920370ISOTYPES HUMAN IGG SUBCLASS EIA KITIsotypes, Inc.

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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