Cleared Traditional

K090967 - BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611
(FDA 510(k) Clearance)

K090967 · Bd Biosciences · Hematology device

Jul 2009

Decision

116d

Days

Class 2

Risk

K090967 is an FDA 510(k) clearance for the BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611. 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 July 31, 2009, 116 days after receiving the submission on April 6, 2009.

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

Submission Details

510(k) Number	K090967 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 06, 2009
Decision Date	July 31, 2009
Days to Decision	116 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF