K024360 is an FDA 510(k) clearance for the INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST. This device is classified as a Helicobacter Pylori (Class I - General Controls, product code LYR).
Submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on June 10, 2003, 162 days after receiving the submission on December 30, 2002.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K024360 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2002 |
| Decision Date | June 10, 2003 |
| Days to Decision | 162 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 |