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FDA 510(k)

GENE-TRAK CAMPYLOBACTER ASSAY

K-Number: K863270 · 1987-08-31

ApplicantIntegrated Genetics
Decision Date1987-08-31
Product CodeLQO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GENE-TRAK CAMPYLOBACTER ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Integrated Genetics. It received FDA 510(k) clearance on 1987-08-31 under 510(k) number K863270. The device is classified under product code LQO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENE-TRAK CAMPYLOBACTER ASSAY?

GENE-TRAK CAMPYLOBACTER ASSAY is a medical device that received FDA 510(k) clearance on 1987-08-31. The listed applicant is Integrated Genetics. The 510(k) number is K863270.

When did GENE-TRAK CAMPYLOBACTER ASSAY receive FDA 510(k) clearance?

GENE-TRAK CAMPYLOBACTER ASSAY received FDA 510(k) clearance on 1987-08-31, under 510(k) number K863270.

Who is the listed applicant for GENE-TRAK CAMPYLOBACTER ASSAY?

The FDA 510(k) record lists Integrated Genetics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENE-TRAK CAMPYLOBACTER ASSAY?

The FDA product code for GENE-TRAK CAMPYLOBACTER ASSAY is LQO.

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Related Devices (Code: LQO)

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.

K894712ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATIONGen-Probe, Inc.K873670SNAP CAMPYLOBACTOR DIAGNOSTIC KITMolecular Biosystems, Inc.K875101VIROGEN CMV ANTIBODY TESTWampole Laboratories

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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