K014038 is an FDA 510(k) clearance for the PYLORITEK VP TEST KIT 5140VP. This device is classified as a Helicobacter Pylori (Class I - General Controls, product code LYR).
Submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on February 8, 2002, 63 days after receiving the submission on December 7, 2001.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K014038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2001 |
| Decision Date | February 08, 2002 |
| Days to Decision | 63 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 |