Cleared Traditional

TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL

K922723 · Simplicity Diagnostics, Inc. · Microbiology
Sep 1992
Decision
105d
Days
Class 1
Risk

About This 510(k) Submission

K922723 is an FDA 510(k) clearance for the TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL, a Antistreptolysin - Titer/streptolysin O Reagent (Class I — General Controls, product code GTQ), submitted by Simplicity Diagnostics, Inc. (Hatboro, US). The FDA issued a Cleared decision on September 18, 1992, 105 days after receiving the submission on June 5, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3720.

Submission Details

510(k) Number K922723 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 1992
Decision Date September 18, 1992
Days to Decision 105 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

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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