Cleared Traditional

CLEARVIEW IM

K981946 · Unipath , Ltd. · Immunology
Dec 1998
Decision
190d
Days
Class 2
Risk

About This 510(k) Submission

K981946 is an FDA 510(k) clearance for the CLEARVIEW IM, a System, Test, Infectious Mononucleosis (Class II — Special Controls, product code KTN), submitted by Unipath , Ltd. (Bedford, GB). The FDA issued a Cleared decision on December 10, 1998, 190 days after receiving the submission on June 3, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5640.

Submission Details

510(k) Number K981946 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 1998
Decision Date December 10, 1998
Days to Decision 190 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code KTN — System, Test, Infectious Mononucleosis
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5640

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