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FDA 510(k)

TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO

K-Number: K920702 · 1992-07-08

ApplicantPharmacia Diagnostics, Inc.
Decision Date1992-07-08
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-07-08 under 510(k) number K920702. 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 TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO?

TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO is a medical device that received FDA 510(k) clearance on 1992-07-08. The listed applicant is Pharmacia Diagnostics, Inc.. The 510(k) number is K920702.

When did TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO receive FDA 510(k) clearance?

TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO received FDA 510(k) clearance on 1992-07-08, under 510(k) number K920702.

Who is the listed applicant for TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO?

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

What is the FDA product code for TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO?

The FDA product code for TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO is LGD.

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Other records listing Pharmacia Diagnostics, 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.

K921011PHARMACIA CMV IGM ELISAK915348EBV-VCA IGM ELISAK914022SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUSK912026DELFIA(R) 17 -OH-PROGESTERON KITK902793RUBELLA IGGK902792TOXOPLASMA GONDII IGG

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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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