Cleared Traditional

EYE SPOT IM TEST

K932688 · J.S. Medical Assoc. · Immunology
Sep 1993
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K932688 is an FDA 510(k) clearance for the EYE SPOT IM TEST, a System, Test, Infectious Mononucleosis (Class II — Special Controls, product code KTN), submitted by J.S. Medical Assoc. (Natick, US). The FDA issued a Cleared decision on September 8, 1993, 97 days after receiving the submission on June 3, 1993. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5640.

Submission Details

510(k) Number K932688 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 1993
Decision Date September 08, 1993
Days to Decision 97 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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