Cleared Traditional

CELL-CHEX

K101335 · Streck · Hematology
Aug 2010
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K101335 is an FDA 510(k) clearance for the CELL-CHEX, 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 August 23, 2010, 103 days after receiving the submission on May 12, 2010. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K101335 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2010
Decision Date August 23, 2010
Days to Decision 103 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