K905468 is an FDA 510(k) clearance for the PYLORI-G FIAX TEST KIT. This device is classified as a Helicobacter Pylori (Class I - General Controls, product code LYR).
Submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on May 7, 1991, 152 days after receiving the submission on December 6, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K905468 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 1990 |
| Decision Date | May 07, 1991 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LYR — Helicobacter Pylori |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3110 |