Cleared Traditional

CELL-DYN 22 PLUS CONTROL

K111211 · Streck · Hematology
Dec 2011
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K111211 is an FDA 510(k) clearance for the CELL-DYN 22 PLUS CONTROL, a Mixture, Control, White-cell And Red-cell Indices (Class II — Special Controls, product code GLQ), 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 864.8625.

Submission Details

510(k) Number K111211 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 GLQ — Mixture, Control, White-cell And Red-cell Indices
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625