The following data is part of a premarket notification filed by Orion Corp. with the FDA for Immunochemical Assay Of C-reactive Protein.
| Device ID | K860679 |
| 510k Number | K860679 |
| Device Name: | IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN |
| Classification | System, Test, C-reactive Protein |
| Applicant | ORION CORP. P.O. BOX 425 20101 Turku, FI |
| Contact | Timo Raines |
| Correspondent | Timo Raines ORION CORP. P.O. BOX 425 20101 Turku, FI |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-25 |
| Decision Date | 1986-08-04 |