Cleared Traditional

CD4 COUNT

K083926 · Streck · Hematology
Feb 2009
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K083926 is an FDA 510(k) clearance for the CD4 COUNT, a Control, White-cell (Class II — Special Controls, product code GGL), submitted by Streck (La Vista, US). The FDA issued a Cleared decision on February 11, 2009, 42 days after receiving the submission on December 31, 2008. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K083926 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 2008
Decision Date February 11, 2009
Days to Decision 42 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GGL — Control, White-cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625