K973523 is an FDA 510(k) clearance for the ACCUSTAT H. PYLORI ONE STEP TEST. This device is classified as a Helicobacter Pylori (Class I - General Controls, product code LYR).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 3, 1998, 167 days after receiving the submission on September 17, 1997.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K973523 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 1997 |
| Decision Date | March 03, 1998 |
| Days to Decision | 167 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 |