Cleared Traditional

DETERMINATION OF CARBAMAZEPINE

K860047 · Clinical Data, Inc. · Toxicology
Jan 1986
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K860047 is an FDA 510(k) clearance for the DETERMINATION OF CARBAMAZEPINE, a Enzyme Immunoassay, Carbamazepine (Class II — Special Controls, product code KLT), submitted by Clinical Data, Inc. (Boston, US). The FDA issued a Cleared decision on January 22, 1986, 16 days after receiving the submission on January 6, 1986. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K860047 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 1986
Decision Date January 22, 1986
Days to Decision 16 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

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

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