510(k) K013195

Device

HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES

Applicant

Trek Diagnostic Systems, Inc.

510(k) number

K013195

Product code

LTT

Decision

Substantially Equivalent (SESE)

Decision date

2001-11-07

Date received

2001-09-25

Regulation

866.1640

Classification name

Panels, Test, Susceptibility, Antimicrobial

Medical specialty

Microbiology

Review panel

Microbiology

Device class

2

Clearance type

Traditional

Statement or summary

Statement

Third party reviewed

N