ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE


Device Classification Name

helicobacter pylori

510(k) Number K024350
Device Name ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE
Original Applicant
ACON LABORATORIES, INC.
4108 sorrento valley blvd.
san diego, 
CA 
92121

Original Contact edward tung
Regulation Number 866.3110
Classification Product Code
LYR  
Date Received 12/30/2002
Decision Date 04/02/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No