Cleared Traditional

ASCA-CHEK

K071711 · Techlab Inc., Corporate Research Center · Immunology
Nov 2007
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K071711 is an FDA 510(k) clearance for the ASCA-CHEK, a Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) (Class II — Special Controls, product code NBT), submitted by Techlab Inc., Corporate Research Center (Blacksburg, US). The FDA issued a Cleared decision on November 7, 2007, 138 days after receiving the submission on June 22, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5785.

Submission Details

510(k) Number K071711 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2007
Decision Date November 07, 2007
Days to Decision 138 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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