The following data is part of a premarket notification filed by Orion Diagnostica Oy with the FDA for Quikread Crp Calibrator Set.
| Device ID | K042625 |
| 510k Number | K042625 |
| Device Name: | QUIKREAD CRP CALIBRATOR SET |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | ORION DIAGNOSTICA OY KOIVU MANKKAAN TIE 6 Espoo, FI 02200 |
| Contact | Annikha Rantama |
| Correspondent | Annikha Rantama ORION DIAGNOSTICA OY KOIVU MANKKAAN TIE 6 Espoo, FI 02200 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-27 |
| Decision Date | 2004-11-18 |