The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Immulisa Enhanced Centromere Antibody Elisa.
| Device ID | K151559 |
| 510k Number | K151559 |
| Device Name: | ImmuLisa Enhanced Centromere Antibody ELISA |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 |
| Contact | Kevin Lawson |
| Correspondent | Kevin Lawson IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-10 |
| Decision Date | 2016-03-11 |
| Summary: | summary |