K982790 is an FDA 510(k) clearance for the QUANTA LITE H. PYLORI IGG ELISA. This device is classified as a Helicobacter Pylori (Class I - General Controls, product code LYR).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on November 4, 1998, 86 days after receiving the submission on August 10, 1998.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K982790 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 1998 |
| Decision Date | November 04, 1998 |
| Days to Decision | 86 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 |