The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Immulisa Anca Screen Elisa.
| Device ID | K092601 |
| 510k Number | K092601 |
| Device Name: | IMMULISA ANCA SCREEN ELISA |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 -2120 |
| Contact | Kevin Lawson |
| Correspondent | Kevin Lawson IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 -2120 |
| Product Code | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-24 |
| Decision Date | 2010-10-07 |