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FDA 510(k)

EIA FOR DETECTION OF ANTIBODIES H. PYLORI

K-Number: K905409 · 1991-06-10

ApplicantE-Z-Em, Inc.
Decision Date1991-06-10
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EIA FOR DETECTION OF ANTIBODIES H. PYLORI is the device name listed in this FDA 510(k) record. The listed applicant is E-Z-Em, Inc.. It received FDA 510(k) clearance on 1991-06-10 under 510(k) number K905409. 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 EIA FOR DETECTION OF ANTIBODIES H. PYLORI?

EIA FOR DETECTION OF ANTIBODIES H. PYLORI is a medical device that received FDA 510(k) clearance on 1991-06-10. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K905409.

When did EIA FOR DETECTION OF ANTIBODIES H. PYLORI receive FDA 510(k) clearance?

EIA FOR DETECTION OF ANTIBODIES H. PYLORI received FDA 510(k) clearance on 1991-06-10, under 510(k) number K905409.

Who is the listed applicant for EIA FOR DETECTION OF ANTIBODIES H. PYLORI?

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

What is the FDA product code for EIA FOR DETECTION OF ANTIBODIES H. PYLORI?

The FDA product code for EIA FOR DETECTION OF ANTIBODIES H. PYLORI is LYR.

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Other records listing E-Z-Em, Inc. as applicant

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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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