ELECSYS RUBELLA IGG IMMUNOASSAY— 510(k) K072617

Name: FDA 510(k) clearance K072617
Creator: U.S. Food and Drug Administration
Published: 2008-12-05

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K072617 for ELECSYS RUBELLA IGG IMMUNOASSAY, Substantially Equivalent on 2008-12-05. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 2007-09-17
Decision date: 2008-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFX

view all

K250588 — Access Rubella IgG2025-11-17
K243168 — Alinity i Rubella IgG2025-06-20
K122397 — LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM2012-09-06
K093101 — MAGO 4S2011-01-21
K092587 — BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM2010-12-03

More clearances from Roche Diagnostics Corp.

view all

K130138 — SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM2013-03-15
K101365 — ELECSYS CA 19-9 CALCHECK 52010-10-05
K100853 — COBAS 8000 MODULAR SERIES ANALYZER2010-09-09
K101196 — ACCU-CHEK ULTRFLEX INFUSION SET2010-08-27
K093664 — AMPHETAMINES II ASSAY2010-07-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.