LQN · Class II · 21 CFR 866.3510

FDA Product Code LQN: Latex Agglutination Assay, Rubella

Leading manufacturers include Orion Corp., Armkel, LLC and Sienna Biotech, Inc..

13
Total
13
Cleared
150d
Avg days
1985
Since

FDA 510(k) Cleared Latex Agglutination Assay, Rubella Devices (Product Code LQN)

13 devices
1–13 of 13
Cleared Apr 24, 1997
COPALIS TORC TOTAL ANTIBODY ASSAY
K970931
Sienna Biotech, Inc.
Microbiology · 48d
Cleared Oct 31, 1996
COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS
K961784
Sienna Biotech, Inc.
Microbiology · 182d
Cleared Aug 21, 1996
MUREX RUB-EX
K954920
Murex Diagnostics, Inc.
Microbiology · 300d
Cleared Jan 17, 1996
COLORSLIDER RUBELLA
K952544
Seradyn, Inc.
Microbiology · 229d
Cleared May 04, 1992
RUBALEX, MODIFICATION
K912391
Orion Corp.
Microbiology · 346d
Cleared Apr 26, 1990
RESUBMITTED MODIFIED RUBALEX
K901637
Orion Corp.
Microbiology · 17d
Cleared Jun 04, 1986
RUBALEX (REVISED VERSION)
K861881
Orion Corp.
Microbiology · 27d
Cleared Mar 12, 1986
RUBALEX
K852788
Orion Corp.
Microbiology · 254d
Cleared May 21, 1985
VIROGEN RUBELLA MICROTITER TEST
K844436
Armkel, LLC
Microbiology · 186d
Cleared May 20, 1985
VIROGEN RUBELLA SLIDE TEST
K844435
Armkel, LLC
Microbiology · 185d

About Product Code LQN - Regulatory Context