Cleared Traditional

CHEMMATE L26 (CD20)

K973390 · Ventana Medical Systems, Inc. · Immunology
Oct 1997
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K973390 is an FDA 510(k) clearance for the CHEMMATE L26 (CD20), a Alpha-1-antitrypsin, Antigen, Antiserum, Control (Class II — Special Controls, product code DEM), submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on October 3, 1997, 85 days after receiving the submission on July 10, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5130.

Submission Details

510(k) Number K973390 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 1997
Decision Date October 03, 1997
Days to Decision 85 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DEM — Alpha-1-antitrypsin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5130

Similar Devices — DEM Alpha-1-antitrypsin, Antigen, Antiserum, Control

All 29
HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
K123256 · The Binding Site Group , Ltd. · Jul 2013
DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
K063610 · Dade Behring, Inc. · Jan 2007
N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN
K053072 · Dade Behring, Inc. · Mar 2006
VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III
K052819 · Ortho-Clinical Diagnostics, Inc. · Dec 2005
QUANTIA A1-AT
K050596 · Biokit, S.A. · May 2005
ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
K031857 · Bayer Diagnostics Corp. · Sep 2003