The following data is part of a premarket notification filed by Euro-diagnostica Ab with the FDA for Immunoscan Pr3-anca.
| Device ID | K971690 |
| 510k Number | K971690 |
| Device Name: | IMMUNOSCAN PR3-ANCA |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | EURO-DIAGNOSTICA AB 155 CIDER MILL RD. Ringoes, NJ 08551 |
| Contact | Karl A Posselt |
| Correspondent | Karl A Posselt EURO-DIAGNOSTICA AB 155 CIDER MILL RD. Ringoes, NJ 08551 |
| Product Code | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-07 |
| Decision Date | 1997-10-29 |