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FDA 510(k)

E. HISTOLYTICA QUIK CHEK

K-Number: K170728 · 2017-06-07

ApplicantTechlab, Inc.
Decision Date2017-06-07
Product CodeKHW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

E. HISTOLYTICA QUIK CHEK is a medical device manufactured by Techlab, Inc.. It received FDA 510(k) clearance on 2017-06-07 under approval number K170728. The device is classified under product code KHW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E. HISTOLYTICA QUIK CHEK?

E. HISTOLYTICA QUIK CHEK is a medical device that received FDA 510(k) clearance on 2017-06-07. It is manufactured by Techlab, Inc.. The 510(k) number is K170728.

When was E. HISTOLYTICA QUIK CHEK approved by the FDA?

E. HISTOLYTICA QUIK CHEK received FDA 510(k) clearance on 2017-06-07, under approval number K170728.

What company makes E. HISTOLYTICA QUIK CHEK?

E. HISTOLYTICA QUIK CHEK is manufactured by Techlab, Inc..

What is the FDA product code for E. HISTOLYTICA QUIK CHEK?

The FDA product code for E. HISTOLYTICA QUIK CHEK is KHW.

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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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