GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT


Device Classification Name

helicobacter pylori

510(k) Number K110899
Device Name GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
Applicant
GOLD STANDARD DIAGNOSTICS
2851 spafford
davis, 
CA 
95618

Applicant Contact napoleon monce
Correspondent
GOLD STANDARD DIAGNOSTICS
2851 spafford
davis, 
CA 
95618

Correspodent Contact napoleon monce
Regulation Number 866.3110
Classification Product Code
LYR  
Date Received 03/30/2011
Decision Date 02/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No