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FDA 510(k)

TOXOPLASMA GONDII IGG ELISA KIT

K-Number: K875258 · 1988-09-30

ApplicantDe Ferris Laboratories, Inc.
Decision Date1988-09-30
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXOPLASMA GONDII IGG ELISA KIT is the device name listed in this FDA 510(k) record. The listed applicant is De Ferris Laboratories, Inc.. It received FDA 510(k) clearance on 1988-09-30 under 510(k) number K875258. 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 IGG ELISA KIT?

TOXOPLASMA GONDII IGG ELISA KIT is a medical device that received FDA 510(k) clearance on 1988-09-30. The listed applicant is De Ferris Laboratories, Inc.. The 510(k) number is K875258.

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

TOXOPLASMA GONDII IGG ELISA KIT received FDA 510(k) clearance on 1988-09-30, under 510(k) number K875258.

Who is the listed applicant for TOXOPLASMA GONDII IGG ELISA KIT?

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

What is the FDA product code for TOXOPLASMA GONDII IGG ELISA KIT?

The FDA product code for TOXOPLASMA GONDII IGG ELISA KIT is LGD.

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Other records listing De Ferris Laboratories, 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.

K880433CYTOMEGALOVIRUS IGG EIA KIT

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

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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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