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FDA 510(k)

TOXOPLASMA GONDII ANTIBODY IGG

K-Number: K822605 · 1982-10-27

ApplicantImmulok, Inc.
Decision Date1982-10-27
Product CodeLJK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXOPLASMA GONDII ANTIBODY IGG is the device name listed in this FDA 510(k) record. The listed applicant is Immulok, Inc.. It received FDA 510(k) clearance on 1982-10-27 under 510(k) number K822605. The device is classified under product code LJK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOXOPLASMA GONDII ANTIBODY IGG?

TOXOPLASMA GONDII ANTIBODY IGG is a medical device that received FDA 510(k) clearance on 1982-10-27. The listed applicant is Immulok, Inc.. The 510(k) number is K822605.

When did TOXOPLASMA GONDII ANTIBODY IGG receive FDA 510(k) clearance?

TOXOPLASMA GONDII ANTIBODY IGG received FDA 510(k) clearance on 1982-10-27, under 510(k) number K822605.

Who is the listed applicant for TOXOPLASMA GONDII ANTIBODY IGG?

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

What is the FDA product code for TOXOPLASMA GONDII ANTIBODY IGG?

The FDA product code for TOXOPLASMA GONDII ANTIBODY IGG is LJK.

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Other records listing Immulok, Inc. 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.

K830971HERPES SIMPLEX VIRUS TYPING REAGENTSK830342CULUTURE SET CHLAMYDIA ISOLATION ANDK830250CVT VIRAL TRANSPORTSK823304RIASET PROLACTIN RIA KITK822785FLUOROSET IMMUNOFLUORESCENT ANTIBODYK823055FLOUROSET IMMUNOFLUORESCENT ANTIBODY

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Related Devices (Code: LJK)

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.

K974261ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROLBoston Biomedica, Inc.K911771ARD(TM) ANTIMICROBIAL REMOVAL DEVICEBd Becton Dickinson Vacutainer Systems PreanalyticK861122THE GOLDEN QUAD TEST (TOXO)Microbiological Research Corp.K861460SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101Widran Urological Group, Ltd.K832069TOXO IPA KIT IAN INDIRECT FLUORESCENTBionetic Laboratory Products

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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