510(k) K871117

Device

Tb Quick Stain(tm) Kit

Applicant

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

510(k) number

K871117

Product code

ICJ

Decision

Substantially Equivalent (SESE)

Decision date

1987-04-03

Date received

1987-03-19

Regulation

864.1850

Classification name

Carbol Night Blue

Medical specialty

Hematology

Review panel

Hematology

Device class

1

Clearance type

Traditional

Third party reviewed

N