The following data is part of a premarket notification filed by Orion Corp. with the FDA for Microalbuminuria Assay.
| Device ID | K862671 |
| 510k Number | K862671 |
| Device Name: | MICROALBUMINURIA ASSAY |
| Classification | Albumin, Antigen, Antiserum, Control |
| 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 | DCF |
| CFR Regulation Number | 866.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-14 |
| Decision Date | 1986-09-18 |