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FDA 510(k)

PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED

K-Number: K923445 · 1992-09-11

ApplicantHycor Biomedical, Inc.
Decision Date1992-09-11
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Hycor Biomedical, Inc.. It received FDA 510(k) clearance on 1992-09-11 under 510(k) number K923445. 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 PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED?

PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED is a medical device that received FDA 510(k) clearance on 1992-09-11. The listed applicant is Hycor Biomedical, Inc.. The 510(k) number is K923445.

When did PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED receive FDA 510(k) clearance?

PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED received FDA 510(k) clearance on 1992-09-11, under 510(k) number K923445.

Who is the listed applicant for PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED?

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

What is the FDA product code for PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED?

The FDA product code for PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED is LYR.

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Other records listing Hycor Biomedical, 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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