The following data is part of a premarket notification filed by Orion Diagnostica, Div. Orion Corp. with the FDA for Pyloriset Eia-g (68926).
| Device ID | K971537 |
| 510k Number | K971537 |
| Device Name: | PYLORISET EIA-G (68926) |
| Classification | Helicobacter Pylori |
| Applicant | ORION DIAGNOSTICA, DIV. ORION CORP. KOIVUMANKKAANTIE 6 Espoo, FI 02200 |
| Contact | Annikka Rantama |
| Correspondent | Annikka Rantama ORION DIAGNOSTICA, DIV. ORION CORP. KOIVUMANKKAANTIE 6 Espoo, FI 02200 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-28 |
| Decision Date | 1997-06-27 |