INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST


Device Classification Name

helicobacter pylori

510(k) Number K024360
Device Name INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST
Original Applicant
ALFA SCIENTIFIC DESIGNS, INC.
12330 stowe dr.
poway, 
CA 
92064

Original Contact naishu wang
Regulation Number 866.3110
Classification Product Code
LYR  
Date Received 12/30/2002
Decision Date 06/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No