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FDA 510(k)

COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI

K-Number: K862814 · 1986-09-30

ApplicantInstitute Virion , Ltd.
Decision Date1986-09-30
Product CodeLQP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI is the device name listed in this FDA 510(k) record. The listed applicant is Institute Virion , Ltd.. It received FDA 510(k) clearance on 1986-09-30 under 510(k) number K862814. The device is classified under product code LQP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI?

COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI is a medical device that received FDA 510(k) clearance on 1986-09-30. The listed applicant is Institute Virion , Ltd.. The 510(k) number is K862814.

When did COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI receive FDA 510(k) clearance?

COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI received FDA 510(k) clearance on 1986-09-30, under 510(k) number K862814.

Who is the listed applicant for COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI?

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

What is the FDA product code for COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI?

The FDA product code for COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI is LQP.

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Other records listing Institute Virion , Ltd. 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.

K843673RESPIRATORY SYNCYTIAL VIRUSK843662MEASLES VIRUS RUBEOLAK843660IN FLUENZA B VIRUSK843657CYTOMEGALOVIRUSK843658H. SIMPLEX VIRUSK843667PARAINFLUENZA 3

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Related Devices (Code: LQP)

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.

K210976Curian CampyMeridian Bioscience, Inc.K211342Sofia 2 Campylobacter FIAQuidel CorporationK191456Campylobacter Quik ChekTechlab, Inc.K191442Campylobacter ChekTechlab, Inc.K173217CAMPYLOBACTER QUIK CHEKTechlab, Inc.K173219CAMPYLOBACTER CHEKTechlab, Inc.

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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