The following data is part of a premarket notification filed by Biochemical Diagnostic, Inc. with the FDA for Anti-gbm Antibodies Quantitative Kit.
| Device ID | K904181 |
| 510k Number | K904181 |
| Device Name: | ANTI-GBM ANTIBODIES QUANTITATIVE KIT |
| Classification | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| Applicant | BIOCHEMICAL DIAGNOSTIC, INC. S-223 70 LUND Sweden, SE |
| Contact | Patrik Swanljung |
| Correspondent | Patrik Swanljung BIOCHEMICAL DIAGNOSTIC, INC. S-223 70 LUND Sweden, SE |
| Product Code | DBL |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-11 |
| Decision Date | 1991-09-10 |