Cleared Traditional

SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN

K850587 · Applications Lab · Immunology
Mar 1985
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K850587 is an FDA 510(k) clearance for the SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN, a Alpha-1-antitrypsin, Antigen, Antiserum, Control (Class II — Special Controls, product code DEM), submitted by Applications Lab (Scarborough, US). The FDA issued a Cleared decision on March 14, 1985, 29 days after receiving the submission on February 13, 1985. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5130.

Submission Details

510(k) Number K850587 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 1985
Decision Date March 14, 1985
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

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