TECHLAB ASCA-CHEK— 510(k) K051927

Substantially Equivalent

Techlab, Inc.

FDA 510(k) clearance K051927 for TECHLAB ASCA-CHEK, Substantially Equivalent on 2006-04-06. Applicant: Techlab, Inc.. Device class: 2.

Clearance details

Applicant: Techlab, Inc.
Product code: Code NBT
Device class: Class 2
Regulation: 21 CFR 866.5785
Advisory panel: Immunology
Date received: 2005-07-18
Decision date: 2006-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blacksburg, VA, US

Download summary PDF View on FDA.gov ↗

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K032860 — IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)2004-03-18

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