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FDA 510(k)

CAMPYLOBACTER CHEK

K-Number: K173219 · 2018-01-22

ApplicantTechlab, Inc.
Decision Date2018-01-22
Product CodeLQP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CAMPYLOBACTER CHEK is a medical device manufactured by Techlab, Inc.. It received FDA 510(k) clearance on 2018-01-22 under approval 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. It is manufactured by Techlab, Inc.. The 510(k) number is K173219.

When was CAMPYLOBACTER CHEK approved by the FDA?

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

What company makes CAMPYLOBACTER CHEK?

CAMPYLOBACTER CHEK is manufactured by Techlab, Inc..

What is the FDA product code for CAMPYLOBACTER CHEK?

The FDA product code for CAMPYLOBACTER CHEK is LQP.

Other Devices by Techlab, Inc.

K171078TRI-COMBO PARASITE SCREEN K170728E. HISTOLYTICA QUIK CHEK K181379H. PYLORI QUIK CHEK K181400H. PYLORI CHEK™ K173217CAMPYLOBACTER QUIK CHEK K191456Campylobacter Quik Chek

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Related Devices (Code: LQP)

K173217CAMPYLOBACTER QUIK CHEKTechlab, Inc. K191456Campylobacter Quik ChekTechlab, Inc. K191442Campylobacter ChekTechlab, Inc. K210976Curian CampyMeridian Bioscience, Inc. K211342Sofia 2 Campylobacter FIAQuidel Corporation

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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