Cleared Traditional

BIORAPID MONONUCLEOSIS

K030215 · Instrumentation Laboratory CO · Immunology
Feb 2003
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K030215 is an FDA 510(k) clearance for the BIORAPID MONONUCLEOSIS, a System, Test, Infectious Mononucleosis (Class II — Special Controls, product code KTN), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on February 24, 2003, 34 days after receiving the submission on January 21, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5640.

Submission Details

510(k) Number K030215 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 2003
Decision Date February 24, 2003
Days to Decision 34 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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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