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FDA 510(k)

PYLORI-G FIAX TEST KIT

K-Number: K905468 · 1991-05-07

ApplicantWhittaker Bioproducts, Inc.
Decision Date1991-05-07
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PYLORI-G FIAX TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Whittaker Bioproducts, Inc.. It received FDA 510(k) clearance on 1991-05-07 under 510(k) number K905468. 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-G FIAX TEST KIT?

PYLORI-G FIAX TEST KIT is a medical device that received FDA 510(k) clearance on 1991-05-07. The listed applicant is Whittaker Bioproducts, Inc.. The 510(k) number is K905468.

When did PYLORI-G FIAX TEST KIT receive FDA 510(k) clearance?

PYLORI-G FIAX TEST KIT received FDA 510(k) clearance on 1991-05-07, under 510(k) number K905468.

Who is the listed applicant for PYLORI-G FIAX TEST KIT?

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

What is the FDA product code for PYLORI-G FIAX TEST KIT?

The FDA product code for PYLORI-G FIAX TEST KIT is LYR.

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Other records listing Whittaker Bioproducts, Inc. as applicant

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.

K911356LEGIONELLA STAT IGG/IGM TEST KITK9132123M IGE SINGLE POINT FAST TESTK904652LYME STAT M TEST KITK904893FIAX LYME M TEST KITK911473EBNA STAT TEST KITK904738PYLORI STAT TEST KIT

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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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