Cleared Traditional

MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET

K900625 · Armkel, LLC · Immunology
Feb 1990
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K900625 is an FDA 510(k) clearance for the MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET, a System, Test, Infectious Mononucleosis (Class II — Special Controls, product code KTN), submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on February 26, 1990, 18 days after receiving the submission on February 8, 1990. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5640.

Submission Details

510(k) Number K900625 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 1990
Decision Date February 26, 1990
Days to Decision 18 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

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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