Cleared Traditional

CELL-DYN 22 PLUS CALIBRATOR

K111204 · Streck · Hematology
Dec 2011
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K111204 is an FDA 510(k) clearance for the CELL-DYN 22 PLUS CALIBRATOR, 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, 2011, 237 days after receiving the submission on April 29, 2011. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8150.

Submission Details

510(k) Number K111204 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2011
Decision Date December 22, 2011
Days to Decision 237 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