Cleared Traditional

ACCURUN 140 RUBELLA IGG POSITIVE CONTROL

K972986 · Boston Biomedica, Inc. · Microbiology
Oct 1997
Decision
58d
Days
Class 1
Risk

About This 510(k) Submission

K972986 is an FDA 510(k) clearance for the ACCURUN 140 RUBELLA IGG POSITIVE CONTROL, a Kit, Serological, Positive Control (Class I — General Controls, product code MJX), submitted by Boston Biomedica, Inc. (West Bridgewater, US). The FDA issued a Cleared decision on October 8, 1997, 58 days after receiving the submission on August 11, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K972986 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 1997
Decision Date October 08, 1997
Days to Decision 58 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

AUDIT MICROCV PROCALCITONIN LINEARITY
K101434 · Aalto Scientific, Ltd. · Jul 2010
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
K030067 · Ortho-Clinical Diagnostics · Jan 2003
SYSCOS IDC - G, IDC, BSC, IDC - G
K974262 · Scantibodies Laboratory, Inc. · Dec 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