Cleared Traditional

CT OIA

K032330 · Thermo Biostar, Inc. · Microbiology
Mar 2004
Decision
217d
Days
Class 1
Risk

About This 510(k) Submission

K032330 is an FDA 510(k) clearance for the CT OIA, a Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (Class I — General Controls, product code LJC), submitted by Thermo Biostar, Inc. (Louisville, US). The FDA issued a Cleared decision on March 2, 2004, 217 days after receiving the submission on July 29, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K032330 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2003
Decision Date March 02, 2004
Days to Decision 217 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LJC — Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3120

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