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FDA 510(k)

CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST

K-Number: K882199 · 1988-10-06

ApplicantAuspharm Intl. , Ltd.
Decision Date1988-10-06
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST is the device name listed in this FDA 510(k) record. The listed applicant is Auspharm Intl. , Ltd.. It received FDA 510(k) clearance on 1988-10-06 under 510(k) number K882199. 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 CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST?

CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST is a medical device that received FDA 510(k) clearance on 1988-10-06. The listed applicant is Auspharm Intl. , Ltd.. The 510(k) number is K882199.

When did CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST receive FDA 510(k) clearance?

CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST received FDA 510(k) clearance on 1988-10-06, under 510(k) number K882199.

Who is the listed applicant for CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST?

The FDA 510(k) record lists Auspharm Intl. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST?

The FDA product code for CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST is LYR.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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