Cleared Traditional

BD FACS SAMPLE PREP ASSISTANT III (SPA III)

K102064 · Becton, Dickinson & CO · Hematology
Mar 2011
Decision
227d
Days
Class 2
Risk

About This 510(k) Submission

K102064 is an FDA 510(k) clearance for the BD FACS SAMPLE PREP ASSISTANT III (SPA III), a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Becton, Dickinson & CO (San Jose, US). The FDA issued a Cleared decision on March 7, 2011, 227 days after receiving the submission on July 23, 2010. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K102064 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 2010
Decision Date March 07, 2011
Days to Decision 227 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