Cleared Abbreviated

ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3

K030102 · Bayer Healthcare, LLC · Chemistry
Jan 2003
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K030102 is an FDA 510(k) clearance for the ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3, a Enzyme Controls (assayed And Unassayed) (Class I — General Controls, product code JJT), submitted by Bayer Healthcare, LLC (New York, US). The FDA issued a Cleared decision on January 24, 2003, 14 days after receiving the submission on January 10, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K030102 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2003
Decision Date January 24, 2003
Days to Decision 14 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJT — Enzyme Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

Similar Devices — JJT Enzyme Controls (assayed And Unassayed)

All 96
SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
K090940 · Astoria-Pacific, Inc. · Dec 2009
MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
K062751 · Quantimetrix Corp. · Oct 2006
CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
K030768 · Cliniqa Corporation · Mar 2003
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
K021498 · Bio-Rad · May 2002
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
K012656 · Bio-Rad · Sep 2001
CARDIASURE CARDIAC MARKERS CONTROL
K993723 · Quantimetrix Corp. · Nov 1999