The following data is part of a premarket notification filed by Orion Diagnostica, Div. Orion Corp. with the FDA for Orion Diagnostica Ultrasensitive Crp Kit, Model 68025, & Orion Diagnostica Ultrasensitive Crp Control, Model 68257.
| Device ID | K022176 |
| 510k Number | K022176 |
| Device Name: | ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257 |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | ORION DIAGNOSTICA, DIV. ORION CORP. KOIVU-MANKKAAN TIE 6 Espoo, FI 02200 |
| Contact | Annikka Rantama |
| Correspondent | Annikka Rantama ORION DIAGNOSTICA, DIV. ORION CORP. KOIVU-MANKKAAN TIE 6 Espoo, FI 02200 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-03 |
| Decision Date | 2002-12-03 |