Cleared Traditional

VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303

K062838 · Ortho-Clinical Diagnostics · Chemistry
Dec 2006
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K062838 is an FDA 510(k) clearance for the VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303, a Immunoassay Method, Troponin Subunit (Class II — Special Controls, product code MMI), submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on December 19, 2006, 89 days after receiving the submission on September 21, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K062838 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2006
Decision Date December 19, 2006
Days to Decision 89 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MMI — Immunoassay Method, Troponin Subunit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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