LFX · Class II · 21 CFR 866.3510

FDA Product Code LFX: Enzyme Linked Immunoabsorbent Assay, Rubella

Leading manufacturers include Abbott Laboratories, Diagnostic Products Corp. and Beckman Coulter, Inc..

94
Total
94
Cleared
172d
Avg days
1979
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 263d recently vs 170d historically

FDA 510(k) Cleared Enzyme Linked Immunoabsorbent Assay, Rubella Devices (Product Code LFX)

94 devices
1–24 of 94
Cleared Nov 17, 2025
Access Rubella IgG
K250588
Beckman Coulter, Inc.
Microbiology · 263d
Cleared Jun 20, 2025
Alinity i Rubella IgG
K243168
Abbott Laboratories
Microbiology · 263d
Cleared Dec 23, 2008
VIDAS RUB IGG
K080766
bioMerieux, Inc.
Microbiology · 280d
Cleared Dec 05, 2008
ELECSYS RUBELLA IGG IMMUNOASSAY
K072617
Roche Diagnostics Corp.
Microbiology · 445d
Cleared Jun 20, 2003
ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
K031606
Beckman Coulter, Inc.
Microbiology · 29d
Cleared Jan 10, 2002
IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6
K012077
Diagnostic Products Corp.
Microbiology · 192d
Cleared Dec 11, 1998
IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS)
K982078
Diagnostic Products Corp.
Microbiology · 179d
Cleared Apr 02, 1997
IMMULITE RUBELLA IGG
K963613
Diagnostic Products Corp.
Microbiology · 204d
Cleared Dec 20, 1996
RUBASCAN CARD TEST
K952721
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 554d
Cleared Sep 24, 1996
AXSYM RUBELLA IGG ANTIBODY ASSAY
K954045
Abbott Laboratories
Microbiology · 392d
Cleared Jul 16, 1996
IMX RUBELLA IGG
K951541
Abbott Laboratories
Microbiology · 470d
Cleared May 14, 1996
ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY
K954318
Abbott Laboratories
Microbiology · 242d
Cleared Dec 19, 1994
IMX RUBELLA IGM ANTIBODY ASSAY
K931059
Abbott Laboratories
Microbiology · 658d
Cleared Jun 23, 1989
IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY
K885295
Abbott Laboratories
Microbiology · 178d
Cleared Jun 23, 1989
IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY
K885297
Abbott Laboratories
Microbiology · 178d
Cleared May 01, 1986
CORDOT R
K854618
Cordis Corp.
Microbiology · 164d
Cleared Nov 16, 1979
ROTAZYME
K791746
Abbott Laboratories
Microbiology · 67d

About Product Code LFX - Regulatory Context

510(k) Submission Activity

94 total 510(k) submissions under product code LFX since 1979, with 94 receiving FDA clearance (average review time: 172 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LFX Product Code

Recent submissions under LFX have taken an average of 263 days to reach a decision - up from 170 days historically. Manufacturers should account for longer review timelines in current project planning.

LFX devices are reviewed by the Microbiology panel. Browse all Microbiology devices →