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FDA 510(k)

CLOSTRIDIUM DIFFICILE TOX-B TEST

K-Number: K935296 · 1994-04-26

ApplicantTechlab, Inc.
Decision Date1994-04-26
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CLOSTRIDIUM DIFFICILE TOX-B TEST is the device name listed in this FDA 510(k) record. The listed applicant is Techlab, Inc.. It received FDA 510(k) clearance on 1994-04-26 under 510(k) number K935296. 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 CLOSTRIDIUM DIFFICILE TOX-B TEST?

CLOSTRIDIUM DIFFICILE TOX-B TEST is a medical device that received FDA 510(k) clearance on 1994-04-26. The listed applicant is Techlab, Inc.. The 510(k) number is K935296.

When did CLOSTRIDIUM DIFFICILE TOX-B TEST receive FDA 510(k) clearance?

CLOSTRIDIUM DIFFICILE TOX-B TEST received FDA 510(k) clearance on 1994-04-26, under 510(k) number K935296.

Who is the listed applicant for CLOSTRIDIUM DIFFICILE TOX-B TEST?

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 CLOSTRIDIUM DIFFICILE TOX-B TEST?

The FDA product code for CLOSTRIDIUM DIFFICILE TOX-B TEST is LLH.

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Related Devices (Code: LLH)

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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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