Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Campylobacter Quik Chek

K-Number: K191456 · 2019-06-20

ApplicantTechlab, Inc.
Decision Date2019-06-20
Product CodeLQP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Campylobacter Quik Chek is the device name listed in this FDA 510(k) record. The listed applicant is Techlab, Inc.. It received FDA 510(k) clearance on 2019-06-20 under 510(k) number K191456. 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 Campylobacter Quik Chek?

Campylobacter Quik Chek is a medical device that received FDA 510(k) clearance on 2019-06-20. The listed applicant is Techlab, Inc.. The 510(k) number is K191456.

When did Campylobacter Quik Chek receive FDA 510(k) clearance?

Campylobacter Quik Chek received FDA 510(k) clearance on 2019-06-20, under 510(k) number K191456.

Who is the listed applicant for Campylobacter Quik Chek?

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

What is the FDA product code for Campylobacter Quik Chek?

The FDA product code for Campylobacter Quik Chek is LQP.

Other records listing Techlab, Inc. 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.

K191442Campylobacter ChekK181400H. PYLORI CHEK™K181379H. PYLORI QUIK CHEKK173219CAMPYLOBACTER CHEKK173217CAMPYLOBACTER QUIK CHEKK171078TRI-COMBO PARASITE SCREEN

View all 8 devices →

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 CorporationK191442Campylobacter ChekTechlab, Inc.K173219CAMPYLOBACTER CHEKTechlab, Inc.K173217CAMPYLOBACTER QUIK 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.

↑