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FDA 510(k)

PYLORI IGG ELISA TEST SYSTEM

K-Number: K961221 · 1996-07-30

ApplicantArmkel, LLC
Decision Date1996-07-30
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PYLORI IGG ELISA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1996-07-30 under 510(k) number K961221. 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 PYLORI IGG ELISA TEST SYSTEM?

PYLORI IGG ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1996-07-30. The listed applicant is Armkel, LLC. The 510(k) number is K961221.

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

PYLORI IGG ELISA TEST SYSTEM received FDA 510(k) clearance on 1996-07-30, under 510(k) number K961221.

Who is the listed applicant for PYLORI IGG ELISA TEST SYSTEM?

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

What is the FDA product code for PYLORI IGG ELISA TEST SYSTEM?

The FDA product code for PYLORI IGG ELISA TEST SYSTEM is LYR.

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Related Devices (Code: LYR)

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.

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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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