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FDA 510(k)

MODIFIED CAPTIA(R) TOXO-M

K-Number: K900655 · 1990-03-06

ApplicantMercia Diagnostics , Ltd.
Decision Date1990-03-06
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFIED CAPTIA(R) TOXO-M 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 1990-03-06 under 510(k) number K900655. 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 MODIFIED CAPTIA(R) TOXO-M?

MODIFIED CAPTIA(R) TOXO-M is a medical device that received FDA 510(k) clearance on 1990-03-06. The listed applicant is Mercia Diagnostics , Ltd.. The 510(k) number is K900655.

When did MODIFIED CAPTIA(R) TOXO-M receive FDA 510(k) clearance?

MODIFIED CAPTIA(R) TOXO-M received FDA 510(k) clearance on 1990-03-06, under 510(k) number K900655.

Who is the listed applicant for MODIFIED CAPTIA(R) TOXO-M?

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 MODIFIED CAPTIA(R) TOXO-M?

The FDA product code for MODIFIED CAPTIA(R) TOXO-M 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-MK896194CAPTIA(R) CMV-GK896295CAPTIA(R) CMV-MK885300CAPTIA(R) RUBELLA-M

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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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