Cleared Traditional

ACCUTEX ASO LATEX TEST

K924247 · J.S. Medical Assoc. · Microbiology
Dec 1992
Decision
105d
Days
Class 1
Risk

About This 510(k) Submission

K924247 is an FDA 510(k) clearance for the ACCUTEX ASO LATEX TEST, a Antistreptolysin - Titer/streptolysin O Reagent (Class I — General Controls, product code GTQ), submitted by J.S. Medical Assoc. (Natick, US). The FDA issued a Cleared decision on December 7, 1992, 105 days after receiving the submission on August 24, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3720.

Submission Details

510(k) Number K924247 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 1992
Decision Date December 07, 1992
Days to Decision 105 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code GTQ — Antistreptolysin - Titer/streptolysin O Reagent
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3720

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