Cleared Traditional

THERMO SCIENTIFIC CYTO-CAL COUNT TUBES

K090810 · Microgenics Corp. · Hematology
Sep 2009
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K090810 is an FDA 510(k) clearance for the THERMO SCIENTIFIC CYTO-CAL COUNT TUBES, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on September 18, 2009, 177 days after receiving the submission on March 25, 2009. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K090810 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2009
Decision Date September 18, 2009
Days to Decision 177 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKZ — Counter, Differential Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5220