Cleared Traditional

SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL

K993987 · Syva Co. · Toxicology
Jan 2000
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K993987 is an FDA 510(k) clearance for the SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL, a Enzyme Immunoassay, Carbamazepine (Class II — Special Controls, product code KLT), submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on January 27, 2000, 64 days after receiving the submission on November 24, 1999. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K993987 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 1999
Decision Date January 27, 2000
Days to Decision 64 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code KLT — Enzyme Immunoassay, Carbamazepine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3645

Similar Devices — KLT Enzyme Immunoassay, Carbamazepine

All 55
Carbamazepine Gen 4
K151578 · Roche Diagnostics Operations (Rdo) · Oct 2015
ABBOTT CARBAMAZEPINE ASSAY
K123518 · Microgenics Corporation · Jun 2013
ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS
K103627 · Abbott Laboratories · Oct 2011
CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS
K063131 · Thermo Electron OY · Oct 2007
ADVIA IMS CARBAMAZEPINE METHOD
K042808 · Bayer Healthcare, LLC · Feb 2005
ONLINE TDM CARBAMAZEPINE
K031902 · Roche Diagnostics Corp. · Sep 2003