Cleared Traditional

CARBAMAZEPINE EIA TEST

K955100 · Diagnostic Reagents, Inc. · Toxicology
Dec 1995
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K955100 is an FDA 510(k) clearance for the CARBAMAZEPINE EIA TEST, a Enzyme Immunoassay, Carbamazepine (Class II — Special Controls, product code KLT), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 13, 1995, 35 days after receiving the submission on November 8, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K955100 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 1995
Decision Date December 13, 1995
Days to Decision 35 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

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

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