Cleared Traditional

K062094 - VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V (FDA 510(k) Clearance)

K062094 · Ortho-Clinical Diagnostics, Inc. · Chemistry device

Nov 2006

Decision

121d

Days

—

Risk

K062094 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V. This device is classified as a Enzyme Immunoassay, Phencyclidine.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on November 22, 2006, 121 days after receiving the submission on July 24, 2006.

This device falls under the Chemistry FDA review panel.

Submission Details

510(k) Number	K062094 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 24, 2006
Decision Date	November 22, 2006
Days to Decision	121 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF