K944903 is an FDA 510(k) clearance for the HP-FAST. This device is classified as a Helicobacter Pylori (Class I - General Controls, product code LYR).
Submitted by Gi Supply (Camp Hill, US). The FDA issued a Cleared decision on April 20, 1995, 198 days after receiving the submission on October 4, 1994.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K944903 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 1994 |
| Decision Date | April 20, 1995 |
| Days to Decision | 198 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 |