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FDA 510(k)

VIDAS TOXO IG6 ASSAY (TX6)

K-Number: K922737 · 1993-05-11

ApplicantBiomerieux Vitek, Inc.
Decision Date1993-05-11
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIDAS TOXO IG6 ASSAY (TX6) is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux Vitek, Inc.. It received FDA 510(k) clearance on 1993-05-11 under 510(k) number K922737. 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 VIDAS TOXO IG6 ASSAY (TX6)?

VIDAS TOXO IG6 ASSAY (TX6) is a medical device that received FDA 510(k) clearance on 1993-05-11. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K922737.

When did VIDAS TOXO IG6 ASSAY (TX6) receive FDA 510(k) clearance?

VIDAS TOXO IG6 ASSAY (TX6) received FDA 510(k) clearance on 1993-05-11, under 510(k) number K922737.

Who is the listed applicant for VIDAS TOXO IG6 ASSAY (TX6)?

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

What is the FDA product code for VIDAS TOXO IG6 ASSAY (TX6)?

The FDA product code for VIDAS TOXO IG6 ASSAY (TX6) is LGD.

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Other records listing Biomerieux Vitek, 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.

K973819VIDAS D-DIMER (DD) ASSAYK972895VIDAS ROTAVIRUS (RTV) ASSAYK965092VIDAS ROTAVIRUS ASSAYK964887VIDAS C. DIFFICILE TOXIN A II ASSAYK955627VIDAS CHLAMYDIA BLOCKING ASSAYK962609GRAM NEGATIVE IDENTIFICATION PLUS CARD

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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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