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FDA 510(k)

TOX A/B QUICK CHEK

K-Number: K050891 · 2005-07-25

ApplicantTechlab, Inc.
Decision Date2005-07-25
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOX A/B QUICK 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 2005-07-25 under 510(k) number K050891. The device is classified under product code LLH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOX A/B QUICK CHEK?

TOX A/B QUICK CHEK is a medical device that received FDA 510(k) clearance on 2005-07-25. The listed applicant is Techlab, Inc.. The 510(k) number is K050891.

When did TOX A/B QUICK CHEK receive FDA 510(k) clearance?

TOX A/B QUICK CHEK received FDA 510(k) clearance on 2005-07-25, under 510(k) number K050891.

Who is the listed applicant for TOX A/B QUICK 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 TOX A/B QUICK CHEK?

The FDA product code for TOX A/B QUICK CHEK is LLH.

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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 ChekK191456Campylobacter Quik ChekK181400H. PYLORI CHEK™K181379H. PYLORI QUIK CHEKK173217CAMPYLOBACTER QUIK CHEKK173219CAMPYLOBACTER CHEK

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Related Devices (Code: LLH)

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.

K193490SensiTox C. difficile Toxin TestFirst Light Diagnostics, Inc.K102242OSOM C. DIFFICILE TOXIN A/B TESTGenzyme CorporationK091109XPERT C. DIFFICILECepheidK090239PROGASTRO CD ASSAYProdesse, Inc.K082499C. DIFF QUIK CHEK COMPLETETechlab, Inc.K081920BD GENEOHM CDIFF ASSAYBd Diagnostics (Geneohm Sciences, 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.

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