The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Accustat H. Pylori One Step Test.
| Device ID | K973523 |
| 510k Number | K973523 |
| Device Name: | ACCUSTAT H. PYLORI ONE STEP TEST |
| Classification | Helicobacter Pylori |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Mike Flis |
| Correspondent | Mike Flis BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-17 |
| Decision Date | 1998-03-03 |
| Summary: | summary |