Cleared Traditional

XN CAL PF

K141955 · Streck · Hematology
Dec 2014
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K141955 is an FDA 510(k) clearance for the XN CAL PF, 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 5, 2014, 140 days after receiving the submission on July 18, 2014. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8150.

Submission Details

510(k) Number K141955 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2014
Decision Date December 05, 2014
Days to Decision 140 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