Cleared Abbreviated

VITROS Immunodiagnostic Products Insulin Calibrators

K171168 · Ortho-Clinical Diagnostics · Chemistry
May 2017
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K171168 is an FDA 510(k) clearance for the VITROS Immunodiagnostic Products Insulin Calibrators, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on May 16, 2017, 25 days after receiving the submission on April 21, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K171168 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 2017
Decision Date May 16, 2017
Days to Decision 25 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIT — Calibrator, Secondary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150