The following data is part of a premarket notification filed by Orion Diagnostica Oy with the FDA for Quickread System: Quickread Crp Kit, Model 06085; Quickread 101 Instrument, Model 06088; Quickread Crp Control Set, Mode.
| Device ID | K042442 |
| 510k Number | K042442 |
| Device Name: | QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| 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 | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-09 |
| Decision Date | 2004-09-24 |