Cleared Traditional

ACCUTEX IM LATEX TEST

K932551 · J.S. Medical Assoc. · Immunology
Aug 1993
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K932551 is an FDA 510(k) clearance for the ACCUTEX IM LATEX 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 August 9, 1993, 75 days after receiving the submission on May 26, 1993. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5640.

Submission Details

510(k) Number K932551 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 1993
Decision Date August 09, 1993
Days to Decision 75 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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