CLOSTRIDIUM DIFFICILE TOX-B TEST— 510(k) K935296

Substantially Equivalent

Techlab, Inc.

FDA 510(k) clearance K935296 for CLOSTRIDIUM DIFFICILE TOX-B TEST, Substantially Equivalent on 1994-04-26. Applicant: Techlab, Inc.. Device class: 1.

Clearance details

Applicant: Techlab, Inc.
Product code: Code LLH
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1993-11-03
Decision date: 1994-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blacksburg, VA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.