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FDA 510(k)

PYLORI STAT TEST KIT

K-Number: K904738 · 1991-05-07

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

Device Summary

PYLORI STAT 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 K904738. 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 STAT TEST KIT?

PYLORI STAT 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 K904738.

When did PYLORI STAT TEST KIT receive FDA 510(k) clearance?

PYLORI STAT TEST KIT received FDA 510(k) clearance on 1991-05-07, under 510(k) number K904738.

Who is the listed applicant for PYLORI STAT 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 STAT TEST KIT?

The FDA product code for PYLORI STAT TEST KIT is LYR.

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Other records listing Whittaker Bioproducts, Inc. as applicant

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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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