Cleared Traditional

INNOFLUOR CARBAMAZEPINE REAGENT SET

K893507 · Innotron of Oregon, Inc. · Chemistry
Aug 1989
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K893507 is an FDA 510(k) clearance for the INNOFLUOR CARBAMAZEPINE REAGENT SET, a Enzyme Immunoassay, Carbamazepine (Class II — Special Controls, product code KLT), submitted by Innotron of Oregon, Inc. (Portland, US). The FDA issued a Cleared decision on August 11, 1989, 98 days after receiving the submission on May 5, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K893507 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 1989
Decision Date August 11, 1989
Days to Decision 98 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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