Cleared Traditional

QM300 APOLIPOPROTEIN A-I ANTIBODY PACK

K883713 · Kallestad Diag, A Div. of Erbamont, Inc. · Immunology
Oct 1988
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K883713 is an FDA 510(k) clearance for the QM300 APOLIPOPROTEIN A-I ANTIBODY PACK, a Apolipoproteins (Class I — General Controls, product code MSJ), submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on October 19, 1988, 50 days after receiving the submission on August 30, 1988. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K883713 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 1988
Decision Date October 19, 1988
Days to Decision 50 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code MSJ — Apolipoproteins
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

Similar Devices — MSJ Apolipoproteins

All 49
DIAZYME APOLIPOPROTEIN A-1 ASSAY
K072977 · General Atomics · Jul 2008
DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX
K073488 · Diazyme Laboratories · Mar 2008
APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
K061377 · Pointe Scientific, Inc., · Mar 2007
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
K063608 · Dade Behring, Inc. · Feb 2007
8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
K992662 · Bayer Corp. · Feb 2000
SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
K970314 · Beckman Instruments, Inc. · Apr 1997