Cleared Traditional

DRYSPOT INFECTIOUS MONONUCLEOSIS KIT

K982634 · Oxoid , Ltd. · Immunology
Jan 1999
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K982634 is an FDA 510(k) clearance for the DRYSPOT INFECTIOUS MONONUCLEOSIS KIT, a System, Test, Infectious Mononucleosis (Class II — Special Controls, product code KTN), submitted by Oxoid , Ltd. (Basingstoke, GB). The FDA issued a Cleared decision on January 28, 1999, 184 days after receiving the submission on July 28, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5640.

Submission Details

510(k) Number K982634 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 1998
Decision Date January 28, 1999
Days to Decision 184 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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