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FDA 510(k)

THE GOLDEN QUAD TEST (TOXO)

K-Number: K861122 · 1987-02-02

ApplicantMicrobiological Research Corp.
Decision Date1987-02-02
Product CodeLJK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

THE GOLDEN QUAD TEST (TOXO) is the device name listed in this FDA 510(k) record. The listed applicant is Microbiological Research Corp.. It received FDA 510(k) clearance on 1987-02-02 under 510(k) number K861122. 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 THE GOLDEN QUAD TEST (TOXO)?

THE GOLDEN QUAD TEST (TOXO) is a medical device that received FDA 510(k) clearance on 1987-02-02. The listed applicant is Microbiological Research Corp.. The 510(k) number is K861122.

When did THE GOLDEN QUAD TEST (TOXO) receive FDA 510(k) clearance?

THE GOLDEN QUAD TEST (TOXO) received FDA 510(k) clearance on 1987-02-02, under 510(k) number K861122.

Who is the listed applicant for THE GOLDEN QUAD TEST (TOXO)?

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

What is the FDA product code for THE GOLDEN QUAD TEST (TOXO)?

The FDA product code for THE GOLDEN QUAD TEST (TOXO) is LJK.

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Other records listing Microbiological Research Corp. 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.

K883011MRI NEO-TRYP TRYPSIN RIAK861123THE GOLDEN QUAD TEST (CMV)K861121THE GOLDEN QUAD TEST (EBV)K861120THE GOLDEN QUAD TEST (HSV)K860450THE CMV-IGM TESTK843138CMV TEST

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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 PreanalyticK861460SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101Widran Urological Group, Ltd.K832069TOXO IPA KIT IAN INDIRECT FLUORESCENTBionetic Laboratory ProductsK822605TOXOPLASMA GONDII ANTIBODY IGGImmulok, 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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