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FDA 510(k)

C. DIFFICILE TOX A/B II

K-Number: K003306 · 2000-11-22

ApplicantTechlab, Inc.
Decision Date2000-11-22
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

C. DIFFICILE TOX A/B II is the device name listed in this FDA 510(k) record. The listed applicant is Techlab, Inc.. It received FDA 510(k) clearance on 2000-11-22 under 510(k) number K003306. 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 C. DIFFICILE TOX A/B II?

C. DIFFICILE TOX A/B II is a medical device that received FDA 510(k) clearance on 2000-11-22. The listed applicant is Techlab, Inc.. The 510(k) number is K003306.

When did C. DIFFICILE TOX A/B II receive FDA 510(k) clearance?

C. DIFFICILE TOX A/B II received FDA 510(k) clearance on 2000-11-22, under 510(k) number K003306.

Who is the listed applicant for C. DIFFICILE TOX A/B II?

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 C. DIFFICILE TOX A/B II?

The FDA product code for C. DIFFICILE TOX A/B II is LLH.

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Related Devices (Code: LLH)

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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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