Cleared Traditional

VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS

K060480 · Ortho-Clinical Diagnostics · Chemistry
Jul 2006
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K060480 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS, a Radioimmunoassay, Cortisol (Class II — Special Controls, product code CGR), submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on July 3, 2006, 130 days after receiving the submission on February 23, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number K060480 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 2006
Decision Date July 03, 2006
Days to Decision 130 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGR — Radioimmunoassay, Cortisol
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1205

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