Cleared Traditional

ELECSYS RUBELLA IGG IMMUNOASSAY

K072617 · Roche Diagnostics Corp. · Microbiology
Dec 2008
Decision
445d
Days
Class 2
Risk

About This 510(k) Submission

K072617 is an FDA 510(k) clearance for the ELECSYS RUBELLA IGG IMMUNOASSAY, a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on December 5, 2008, 445 days after receiving the submission on September 17, 2007. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K072617 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2007
Decision Date December 05, 2008
Days to Decision 445 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LFX — Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3510

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