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FDA 510(k)

TOXO IGM ELISA TEST

K-Number: K903324 · 1990-10-16

ApplicantGull Laboratories, Inc.
Decision Date1990-10-16
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXO IGM ELISA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Gull Laboratories, Inc.. It received FDA 510(k) clearance on 1990-10-16 under 510(k) number K903324. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOXO IGM ELISA TEST?

TOXO IGM ELISA TEST is a medical device that received FDA 510(k) clearance on 1990-10-16. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K903324.

When did TOXO IGM ELISA TEST receive FDA 510(k) clearance?

TOXO IGM ELISA TEST received FDA 510(k) clearance on 1990-10-16, under 510(k) number K903324.

Who is the listed applicant for TOXO IGM ELISA TEST?

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

What is the FDA product code for TOXO IGM ELISA TEST?

The FDA product code for TOXO IGM ELISA TEST is LGD.

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Other records listing Gull Laboratories, Inc. as applicant

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K983541HSV 1+2 IGG ELISA TESTK971857MUMPS IGG ELISA TESTYK962343TOXO IGG ELISA TESTK935730EBNA IGG ELISA TESTK940093EBV-EA(D) IGG ELISA TESTK941046VZV IGG ELISA TEST

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Related Devices (Code: LGD)

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.

K242022Access Toxo IgGBeckman Coulter, Inc.K242095Access Toxo IgM IIBeckman Coulter, Inc.K233932Alinity i Toxo IgMAbbott LaboratoriesK210596ARCHITECT Toxo IgGAbbott LaboratoriesK162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche DiagnosticsK132234LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG IIDiaSorin, 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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