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FDA 510(k)

CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY

K-Number: K871746 · 1987-07-31

ApplicantMercia Diagnostics , Ltd.
Decision Date1987-07-31
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Mercia Diagnostics , Ltd.. It received FDA 510(k) clearance on 1987-07-31 under 510(k) number K871746. 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 CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY?

CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1987-07-31. The listed applicant is Mercia Diagnostics , Ltd.. The 510(k) number is K871746.

When did CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1987-07-31, under 510(k) number K871746.

Who is the listed applicant for CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY?

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

What is the FDA product code for CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY?

The FDA product code for CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY is LGD.

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Other records listing Mercia Diagnostics , Ltd. 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.

K915479CAPTIA CMV-TAK904524CAPTIA(R) SYPHILIS M, MODIFICATIONK900654MODIFIED CAPTIA(R) SYPHILIS-MK896295CAPTIA(R) CMV-MK900655MODIFIED CAPTIA(R) TOXO-MK896194CAPTIA(R) CMV-G

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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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