The following data is part of a premarket notification filed by Orion Diagnostica, Div. Orion Corp. with the FDA for Pyloriset Dry.
| Device ID | K942974 |
| 510k Number | K942974 |
| Device Name: | PYLORISET DRY |
| Classification | Helicobacter Pylori |
| Applicant | ORION DIAGNOSTICA, DIV. ORION CORP. KOIVU-MANKKAAN TIE 6 P.O. BOX 83 02101 Espoo, FI 02200 |
| Contact | Timo Raines |
| Correspondent | Timo Raines ORION DIAGNOSTICA, DIV. ORION CORP. KOIVU-MANKKAAN TIE 6 P.O. BOX 83 02101 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 | 1994-06-20 |
| Decision Date | 1995-04-05 |