Cleared Special

EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229

K010812 · Syva Co., Dade Behring, Inc. · Chemistry
Apr 2001
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K010812 is an FDA 510(k) clearance for the EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229, a Enzyme Immunoassay, Procainamide (Class II — Special Controls, product code LAR), submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on April 13, 2001, 25 days after receiving the submission on March 19, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K010812 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2001
Decision Date April 13, 2001
Days to Decision 25 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LAR — Enzyme Immunoassay, Procainamide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320

Similar Devices — LAR Enzyme Immunoassay, Procainamide

All 24
ONLINE TDM PROCAINAMIDE
K060773 · Roche Diagnostics Corp. · Aug 2006
DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110
K032573 · Dade Behring, Inc. · Oct 2003
PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K971716 · Bayer Corp. · Jun 1997
CEDIA N-ACETYLPROCAINAMIDE ASSAY
K963306 · Boehringer Mannheim Corp. · Oct 1996
CEDIA PROCAINAMIDE ASSAY
K962099 · Boehringer Mannheim Corp. · Aug 1996
PROCAINAMIDE ENZYME IMMUNOASSAY
K962463 · Diagnostic Reagents, Inc. · Aug 1996