MJX · Class I · 21 CFR 862.1660

FDA Product Code MJX: Kit, Serological, Positive Control

Leading manufacturers include Ortho-Clinical Diagnostics, Aalto Scientific, Ltd. and Pb Diagnostic Systems, Inc..

7
Total
7
Cleared
82d
Avg days
1993
Since

FDA 510(k) Cleared Kit, Serological, Positive Control Devices (Product Code MJX)

7 devices
1–7 of 7
Cleared Jul 22, 2010
AUDIT MICROCV PROCALCITONIN LINEARITY
K101434
Aalto Scientific, Ltd.
Microbiology · 62d
Cleared Jan 17, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
K030067
Ortho-Clinical Diagnostics
Microbiology · 10d
Cleared Dec 24, 1997
SYSCOS IDC - G, IDC, BSC, IDC - G
K974262
Scantibodies Laboratory, Inc.
Microbiology · 41d
Cleared Oct 08, 1997
ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
K972986
Boston Biomedica, Inc.
Microbiology · 58d
Cleared Mar 10, 1997
TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL
K970100
Simplicity Diagnostics, Inc.
Microbiology · 59d
Cleared Mar 07, 1994
OPUS(R) SEROLOGY CONTROLS, MODIFICATION
K934137
Pb Diagnostic Systems, Inc.
Microbiology · 194d

About Product Code MJX - Regulatory Context