NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY


Device Classification Name

helicobacter pylori

510(k) Number K022356
Device Name NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY
Original Applicant
NICHOLS INSTITUTE DIAGNOSTICS
1311 calle batido
san clemente, 
CA 
92673

Original Contact james a rybski
Regulation Number 866.3110
Classification Product Code
LYR  
Date Received 07/19/2002
Decision Date 10/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No