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 |