The following data is part of a premarket notification filed by Orion Diagnostica, Inc. with the FDA for Immunochemical Determination Of Immunoglobulin G.
| Device ID | K884074 |
| 510k Number | K884074 |
| Device Name: | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G |
| Classification | Gamma Globulin, Antigen, Antiserum, Control |
| Applicant | ORION DIAGNOSTICA, INC. P.O. BOX 83 02101 Espoo, FI |
| Contact | Timo Raines |
| Correspondent | Timo Raines ORION DIAGNOSTICA, INC. P.O. BOX 83 02101 Espoo, FI |
| Product Code | DAH |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-27 |
| Decision Date | 1988-10-27 |