Cleared Traditional

AUDIT MICROCV PROCALCITONIN LINEARITY

K101434 · Aalto Scientific, Ltd. · Microbiology
Jul 2010
Decision
62d
Days
Class 1
Risk

About This 510(k) Submission

K101434 is an FDA 510(k) clearance for the AUDIT MICROCV PROCALCITONIN LINEARITY, a Kit, Serological, Positive Control (Class I — General Controls, product code MJX), submitted by Aalto Scientific, Ltd. (Carlsbad, US). The FDA issued a Cleared decision on July 22, 2010, 62 days after receiving the submission on May 21, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K101434 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 2010
Decision Date July 22, 2010
Days to Decision 62 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

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

Similar Devices — MJX Kit, Serological, Positive Control

VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
K030067 · Ortho-Clinical Diagnostics · Jan 2003
SYSCOS IDC - G, IDC, BSC, IDC - G
K974262 · Scantibodies Laboratory, Inc. · Dec 1997
ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
K972986 · Boston Biomedica, Inc. · Oct 1997
TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL
K970100 · Simplicity Diagnostics, Inc. · Mar 1997
OPUS(R) SEROLOGY CONTROLS, MODIFICATION
K934137 · Pb Diagnostic Systems, Inc. · Mar 1994
OPUS SEROLOGY CONTROLS
K925703 · Pb Diagnostics, Inc. · Apr 1993