MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN


Device Classification Name

panels, test, susceptibility, antimicrobial

510(k) Number K021078
Device Name MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN
Original Applicant
DADE MICROSCAN, INC.
1584 enterprise blvd.
west sacramento, 
CA 
95691

Original Contact cynthia van duker
Regulation Number 866.1640
Classification Product Code
LTT  
Date Received 04/03/2002
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