K110745 is an FDA 510(k) clearance for the HELICOBACTER PYLORI ELISA IGG TEST KIT. This device is classified as a Helicobacter Pylori (Class I - General Controls, product code LYR).
Submitted by Gold Standard Diagnostics (Davis, US). The FDA issued a Cleared decision on March 2, 2012, 351 days after receiving the submission on March 17, 2011.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K110745 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2011 |
| Decision Date | March 02, 2012 |
| Days to Decision | 351 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 |