HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE


Device Classification Name

manual antimicrobial susceptibility test systems

510(k) Number K021339
Device Name HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE
Original Applicant
TREK DIAGNOSTIC SYSTEMS, INC.
29299 clemens rd. suite 1-k
westlake, 
OH 
44145

Original Contact cynithia c knapp
Regulation Number 866.1640
Classification Product Code
JWY  
Date Received 03/07/2002
Decision Date 05/09/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No