Cleared Traditional

X-CAL

K083200 · Streck · Hematology
Feb 2009
Decision
96d
Days
Class 2
Risk

About This 510(k) Submission

K083200 is an FDA 510(k) clearance for the X-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 February 3, 2009, 96 days after receiving the submission on October 30, 2008. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8150.

Submission Details

510(k) Number K083200 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2008
Decision Date February 03, 2009
Days to Decision 96 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