Cleared Traditional

ELECSYS RUBELLA IGM IMMUNOASSAY

K092322 · Roche Diagnostics · Microbiology
Mar 2010
Decision
220d
Days
Class 2
Risk

About This 510(k) Submission

K092322 is an FDA 510(k) clearance for the ELECSYS RUBELLA IGM IMMUNOASSAY, a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on March 12, 2010, 220 days after receiving the submission on August 4, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K092322 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2009
Decision Date March 12, 2010
Days to Decision 220 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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