The following data is part of a premarket notification filed by Orion Diagnostica Oy with the FDA for Orion Diagnostica Uniq Pinp Ria.
| Device ID | K043125 |
| 510k Number | K043125 |
| Device Name: | ORION DIAGNOSTICA UNIQ PINP RIA |
| Classification | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes |
| Applicant | ORION DIAGNOSTICA OY KOIVU MANKKAAN TIE 6 Espoo, FI 02200 |
| Contact | Annikka Rantama |
| Correspondent | Annikka Rantama ORION DIAGNOSTICA OY KOIVU MANKKAAN TIE 6 Espoo, FI 02200 |
| Product Code | CIN |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-12 |
| Decision Date | 2005-05-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438115000082 | K043125 | 000 |