The following data is part of a premarket notification filed by Euro-diagnostica Ab with the FDA for Immunoscan Anti-gbm Quantitative Kit.
| Device ID | K971464 |
| 510k Number | K971464 |
| Device Name: | IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT |
| Classification | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| 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 | DBL |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-22 |
| Decision Date | 1997-10-29 |