Cleared Traditional

TECHLAB ASCA-CHEK

K051927 · Techlab, Inc. · Immunology
Apr 2006
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K051927 is an FDA 510(k) clearance for the TECHLAB ASCA-CHEK, a Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) (Class II — Special Controls, product code NBT), submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on April 6, 2006, 262 days after receiving the submission on July 18, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5785.

Submission Details

510(k) Number K051927 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2005
Decision Date April 06, 2006
Days to Decision 262 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code NBT — Antibodies, Saccharomyces Cerevisiae (s.cerevisiae)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5785

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