K990462 is an FDA 510(k) clearance for the IS H. PYLORI IGG ELISA TEST SYSTEM. This device is classified as a Helicobacter Pylori (Class I - General Controls, product code LYR).
Submitted by Columbia Bioscience, Inc. (Columbia, US). The FDA issued a Cleared decision on September 3, 1999, 203 days after receiving the submission on February 12, 1999.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K990462 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 1999 |
| Decision Date | September 03, 1999 |
| Days to Decision | 203 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 |