Cleared Traditional

ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90

K993028 · Syva Co. · Toxicology
Jan 2000
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K993028 is an FDA 510(k) clearance for the ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90, 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, 140 days after receiving the submission on September 9, 1999. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K993028 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 1999
Decision Date January 27, 2000
Days to Decision 140 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

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