Cleared Traditional

TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL

K970100 · Simplicity Diagnostics, Inc. · Microbiology
Mar 1997
Decision
59d
Days
Class 1
Risk

About This 510(k) Submission

K970100 is an FDA 510(k) clearance for the TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL, a Kit, Serological, Positive Control (Class I — General Controls, product code MJX), submitted by Simplicity Diagnostics, Inc. (Hatboro, US). The FDA issued a Cleared decision on March 10, 1997, 59 days after receiving the submission on January 10, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K970100 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 1997
Decision Date March 10, 1997
Days to Decision 59 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code MJX — Kit, Serological, Positive Control
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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