Cleared Traditional

QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA

K000733 · Inova Diagnostics, Inc. · Immunology
May 2001
Decision
441d
Days
Class 2
Risk

About This 510(k) Submission

K000733 is an FDA 510(k) clearance for the QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA, a Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) (Class II — Special Controls, product code NBT), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on May 21, 2001, 441 days after receiving the submission on March 6, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5785.

Submission Details

510(k) Number K000733 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2000
Decision Date May 21, 2001
Days to Decision 441 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

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

Similar Devices — NBT Antibodies, Saccharomyces Cerevisiae (s.cerevisiae)

All 7
ASCA-CHEK
K071711 · Techlab Inc., Corporate Research Center · Nov 2007
TECHLAB ASCA-CHEK
K051927 · Techlab, Inc. · Apr 2006
AESKULISA ASCA A
K051492 · Aesku, Inc. · Nov 2005
BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT
K042579 · The Binding Site · Jul 2005
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)
K032850 · Immco Diagnostics, Inc. · Mar 2004
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)
K032860 · Immco Diagnostics, Inc. · Mar 2004