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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 the device name listed in this FDA 510(k) record. The listed applicant is Techlab, Inc.. It received FDA 510(k) clearance on 2017-06-07 under 510(k) 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. The listed applicant is Techlab, Inc.. The 510(k) number is K170728.

When did E. HISTOLYTICA QUIK CHEK receive FDA 510(k) clearance?

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

Who is the listed applicant for E. HISTOLYTICA 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 E. HISTOLYTICA QUIK CHEK?

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

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.

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Official Source

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