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FDA 510(k)

VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210

K-Number: K993319 · 2000-05-22

ApplicantbioMerieux, Inc.
Decision Date2000-05-22
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2000-05-22 under 510(k) number K993319. 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 IGG II (TXG) ASSAY MODEL 30 210?

VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 is a medical device that received FDA 510(k) clearance on 2000-05-22. The listed applicant is bioMerieux, Inc.. The 510(k) number is K993319.

When did VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 receive FDA 510(k) clearance?

VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 received FDA 510(k) clearance on 2000-05-22, under 510(k) number K993319.

Who is the listed applicant for VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210?

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

What is the FDA product code for VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210?

The FDA product code for VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 is LGD.

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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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