Cleared Traditional

BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY

K010668 · Bayer Corp. · Microbiology
Jul 2001
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K010668 is an FDA 510(k) clearance for the BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM 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 July 5, 2001, 121 days after receiving the submission on March 6, 2001. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K010668 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2001
Decision Date July 05, 2001
Days to Decision 121 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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