C. DIFFICILE TOX A/B II— 510(k) K003306

Substantially Equivalent

Techlab, Inc.

FDA 510(k) clearance K003306 for C. DIFFICILE TOX A/B II, Substantially Equivalent on 2000-11-22. 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: 2000-10-20
Decision date: 2000-11-22
Decision: Substantially Equivalent
Clearance type: Special
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.