Cleared Traditional

TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL

K922726 · Simplicity Diagnostics, Inc. · Immunology
Oct 1992
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K922726 is an FDA 510(k) clearance for the TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL, a System, Test, Infectious Mononucleosis (Class II — Special Controls, product code KTN), submitted by Simplicity Diagnostics, Inc. (Hatboro, US). The FDA issued a Cleared decision on October 5, 1992, 122 days after receiving the submission on June 5, 1992. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5640.

Submission Details

510(k) Number K922726 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 1992
Decision Date October 05, 1992
Days to Decision 122 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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