The following data is part of a premarket notification filed by Wieslab Ab with the FDA for Wielisa Anti-gbm Test System.
| Device ID | K974169 |
| 510k Number | K974169 |
| Device Name: | WIELISA ANTI-GBM TEST SYSTEM |
| Classification | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| Applicant | WIESLAB AB 1306 BAILES LN. SUITE F Frederick, MD 21701 |
| Contact | William L Boteler |
| Correspondent | William L Boteler WIESLAB AB 1306 BAILES LN. SUITE F Frederick, MD 21701 |
| Product Code | DBL |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-05 |
| Decision Date | 1998-02-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07340058410721 | K974169 | 000 |