K022356 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY. This device is classified as a Helicobacter Pylori (Class I - General Controls, product code LYR).
Submitted by Nichols Institute Diagnostics (San Clemente, US). The FDA issued a Cleared decision on October 25, 2002, 98 days after receiving the submission on July 19, 2002.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K022356 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2002 |
| Decision Date | October 25, 2002 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LYR — Helicobacter Pylori |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3110 |