MICROSTREP PLUS PANEL, AZITHROMYCIN


Device Classification Name

manual antimicrobial susceptibility test systems

510(k) Number K021169
Device Name MICROSTREP PLUS PANEL, AZITHROMYCIN
Original Applicant
DADE MICROSCAN, INC.
1584 enterprise blvd.
west sacramento, 
CA 
95691

Original Contact cynthia van duker
Regulation Number 866.1640
Classification Product Code
JWY  
Date Received 04/11/2002
Decision Date 06/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No