K012588 is an FDA 510(k) clearance for the OXOID PYLORI TEST KIT, MODEL DR0130M. This device is classified as a Helicobacter Pylori (Class I - General Controls, product code LYR).
Submitted by Oxoid , Ltd. (Basingstoke, GB). The FDA issued a Cleared decision on December 10, 2001, 122 days after receiving the submission on August 10, 2001.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K012588 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2001 |
| Decision Date | December 10, 2001 |
| Days to Decision | 122 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 |