Cleared Traditional

VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS

K062165 · Ortho-Clinical Diagnostics · Chemistry
Jan 2007
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K062165 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS, a Enzyme Immunoassay, Barbiturate (Class II — Special Controls, product code DIS), submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on January 5, 2007, 161 days after receiving the submission on July 28, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K062165 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 2006
Decision Date January 05, 2007
Days to Decision 161 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DIS — Enzyme Immunoassay, Barbiturate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3150

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