K033067 is an FDA 510(k) clearance for the PYLORI IGG. This device is classified as a Helicobacter Pylori (Class I - General Controls, product code LYR).
Submitted by Trinity Biotech USA (Jamestown, US). The FDA issued a Cleared decision on November 26, 2003, 58 days after receiving the submission on September 29, 2003.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K033067 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2003 |
| Decision Date | November 26, 2003 |
| Days to Decision | 58 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 |