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FDA 510(k)

VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192

K-Number: K001460 · 2000-10-04

ApplicantbioMerieux, Inc.
Decision Date2000-10-04
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2000-10-04 under 510(k) number K001460. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192?

VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 is a medical device that received FDA 510(k) clearance on 2000-10-04. The listed applicant is bioMerieux, Inc.. The 510(k) number is K001460.

When did VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 receive FDA 510(k) clearance?

VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 received FDA 510(k) clearance on 2000-10-04, under 510(k) number K001460.

Who is the listed applicant for VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192?

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 H. PYLORI IGG (HPY) ASSAY, MODEL 30 192?

The FDA product code for VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 is LYR.

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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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