Cleared Traditional

BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY

K010755 · Bayer Corp. · Microbiology
Aug 2001
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K010755 is an FDA 510(k) clearance for the BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY, a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II — Special Controls, product code LGD), submitted by Bayer Corp. (Medfield, US). The FDA issued a Cleared decision on August 20, 2001, 160 days after receiving the submission on March 13, 2001. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K010755 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2001
Decision Date August 20, 2001
Days to Decision 160 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LGD — Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3780

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