Cleared Traditional

ADVIA CENTAUR RUBELLA IGG ASSAY

K003412 · Bayer Corp. · Microbiology
Apr 2001
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K003412 is an FDA 510(k) clearance for the ADVIA CENTAUR RUBELLA IGG ASSAY, a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by Bayer Corp. (Medfield, US). The FDA issued a Cleared decision on April 13, 2001, 162 days after receiving the submission on November 2, 2000. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K003412 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 2000
Decision Date April 13, 2001
Days to Decision 162 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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