Cleared Traditional

CELL-CHEX WITH CPPD CRYSTALS

K110718 · Streck · Hematology
May 2011
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K110718 is an FDA 510(k) clearance for the CELL-CHEX WITH CPPD CRYSTALS, 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 May 26, 2011, 72 days after receiving the submission on March 15, 2011. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K110718 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2011
Decision Date May 26, 2011
Days to Decision 72 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