K052708 is an FDA 510(k) clearance for the PYLO-PLUS. This device is classified as a Helicobacter Pylori (Class I - General Controls, product code LYR).
Submitted by Arj Medical, Inc. (Oldsmar, US). The FDA issued a Cleared decision on May 1, 2006, 214 days after receiving the submission on September 29, 2005.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K052708 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2005 |
| Decision Date | May 01, 2006 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LYR — Helicobacter Pylori |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3110 |