FDA 510(k)

CAMPYLOBACTER CHEK

K-Number: K173219 · 2018-01-22

Decision Date2018-01-22

Product CodeLQP

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

CAMPYLOBACTER 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 2018-01-22 under 510(k) number K173219. 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 CHEK?

CAMPYLOBACTER CHEK is a medical device that received FDA 510(k) clearance on 2018-01-22. The listed applicant is Techlab, Inc.. The 510(k) number is K173219.

When did CAMPYLOBACTER CHEK receive FDA 510(k) clearance?

CAMPYLOBACTER CHEK received FDA 510(k) clearance on 2018-01-22, under 510(k) number K173219.

Who is the listed applicant for CAMPYLOBACTER 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 CHEK?

The FDA product code for CAMPYLOBACTER 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.

K191456Campylobacter Quik Chek K191442Campylobacter Chek K181400H. PYLORI CHEK™K181379H. PYLORI QUIK CHEK K173217CAMPYLOBACTER QUIK CHEK K171078TRI-COMBO PARASITE SCREEN

View all 8 devices →

Related Devices (Code: LQP)

K210976Curian CampyMeridian Bioscience, Inc.K211342Sofia 2 Campylobacter FIAQuidel Corporation K191456Campylobacter Quik ChekTechlab, Inc.K191442Campylobacter 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.