Cleared Traditional

XN CAL

K120745 · Streck · Hematology
Oct 2012
Decision
221d
Days
Class 2
Risk

About This 510(k) Submission

K120745 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 October 19, 2012, 221 days after receiving the submission on March 12, 2012. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8150.

Submission Details

510(k) Number K120745 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 2012
Decision Date October 19, 2012
Days to Decision 221 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