Cleared Traditional

XN CAL

K160585 · Streck · Hematology
Dec 2016
Decision
296d
Days
Class 2
Risk

About This 510(k) Submission

K160585 is an FDA 510(k) clearance for the XN CAL, a Calibrator For Cell Indices (Class II — Special Controls, product code KRX), submitted by Streck (La Vista, US). The FDA issued a Cleared decision on December 22, 2016, 296 days after receiving the submission on March 1, 2016. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8150.

Submission Details

510(k) Number K160585 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2016
Decision Date December 22, 2016
Days to Decision 296 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KRX — Calibrator For Cell Indices
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8150