The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Nichols Advantage Chemiluminescence Helicobactor Pylori Igg Antibodies Immunoassay.
Device ID | K022356 |
510k Number | K022356 |
Device Name: | NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY |
Classification | Helicobacter Pylori |
Applicant | NICHOLS INSTITUTE DIAGNOSTICS 1311 CALLE BATIDO San Clemente, CA 92673 |
Contact | James A Rybski |
Correspondent | James A Rybski NICHOLS INSTITUTE DIAGNOSTICS 1311 CALLE BATIDO San Clemente, CA 92673 |
Product Code | LYR |
CFR Regulation Number | 866.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-19 |
Decision Date | 2002-10-25 |
Summary: | summary |