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FDA 510(k)

HYCOR PYLORAGEN HELICOBACTER PYLORI TEST

K-Number: K912255 · 1991-10-11

ApplicantHycor Biomedical, Inc.
Decision Date1991-10-11
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HYCOR PYLORAGEN HELICOBACTER PYLORI TEST 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 1991-10-11 under 510(k) number K912255. 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 HYCOR PYLORAGEN HELICOBACTER PYLORI TEST?

HYCOR PYLORAGEN HELICOBACTER PYLORI TEST is a medical device that received FDA 510(k) clearance on 1991-10-11. The listed applicant is Hycor Biomedical, Inc.. The 510(k) number is K912255.

When did HYCOR PYLORAGEN HELICOBACTER PYLORI TEST receive FDA 510(k) clearance?

HYCOR PYLORAGEN HELICOBACTER PYLORI TEST received FDA 510(k) clearance on 1991-10-11, under 510(k) number K912255.

Who is the listed applicant for HYCOR PYLORAGEN HELICOBACTER PYLORI TEST?

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 HYCOR PYLORAGEN HELICOBACTER PYLORI TEST?

The FDA product code for HYCOR PYLORAGEN HELICOBACTER PYLORI TEST is 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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