Cleared Traditional

K060375 - BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 (FDA 510(k) Clearance)

K060375 · Bd Biosciences · Hematology device

Jun 2006

Decision

113d

Days

Class 2

Risk

K060375 is an FDA 510(k) clearance for the BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).

Submitted by Bd Biosciences (San Jose, US). The FDA issued a Cleared decision on June 6, 2006, 113 days after receiving the submission on February 13, 2006.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number	K060375 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 13, 2006
Decision Date	June 06, 2006
Days to Decision	113 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF