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FDA 510(k)

HELICOBACTER PYLORI IGG ELISA

K-Number: K041238 · 2004-12-13

ApplicantBiohit Plc
Decision Date2004-12-13
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HELICOBACTER PYLORI IGG ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Biohit Plc. It received FDA 510(k) clearance on 2004-12-13 under 510(k) number K041238. 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 HELICOBACTER PYLORI IGG ELISA?

HELICOBACTER PYLORI IGG ELISA is a medical device that received FDA 510(k) clearance on 2004-12-13. The listed applicant is Biohit Plc. The 510(k) number is K041238.

When did HELICOBACTER PYLORI IGG ELISA receive FDA 510(k) clearance?

HELICOBACTER PYLORI IGG ELISA received FDA 510(k) clearance on 2004-12-13, under 510(k) number K041238.

Who is the listed applicant for HELICOBACTER PYLORI IGG ELISA?

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

What is the FDA product code for HELICOBACTER PYLORI IGG ELISA?

The FDA product code for HELICOBACTER PYLORI IGG ELISA is LYR.

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Related Devices (Code: 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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