The following data is part of a premarket notification filed by Immuno Concepts, Inc. with the FDA for Relisa Mpo-anca Test System For Antibodies To Myeloperoxidase, Model # 7096-15.
| Device ID | K013285 |
| 510k Number | K013285 |
| Device Name: | RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | IMMUNO CONCEPTS, INC. 2280 SPRINGLAKE RD. SUITE 106 Dallas, TX 75234 |
| Contact | Eric S Hoy |
| Correspondent | Eric S Hoy IMMUNO CONCEPTS, INC. 2280 SPRINGLAKE RD. SUITE 106 Dallas, TX 75234 |
| Product Code | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-02 |
| Decision Date | 2001-11-14 |
| Summary: | summary |