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FDA 510(k)

CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT

K-Number: K923463 · 1993-02-01

ApplicantTechlab, Inc.
Decision Date1993-02-01
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Techlab, Inc.. It received FDA 510(k) clearance on 1993-02-01 under 510(k) number K923463. 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 TOXIN/ANTITOXIN KIT?

CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT is a medical device that received FDA 510(k) clearance on 1993-02-01. The listed applicant is Techlab, Inc.. The 510(k) number is K923463.

When did CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT receive FDA 510(k) clearance?

CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT received FDA 510(k) clearance on 1993-02-01, under 510(k) number K923463.

Who is the listed applicant for CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT?

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 TOXIN/ANTITOXIN KIT?

The FDA product code for CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT is LLH.

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Other records listing Techlab, Inc. as applicant

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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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