The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Immulisa Enhanced Gliadin Iga Antibody Elisa, Immulisa Enhanced Gliadin Igg Antibody Elisa.
| Device ID | K163177 |
| 510k Number | K163177 |
| Device Name: | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA |
| Classification | Antibodies, Gliadin |
| Applicant | IMMCO DIAGNOSTICS, INC. 9870 Hollingson Rd Clarence, NY 14031 |
| Contact | Kevin Lawson |
| Correspondent | Kevin Lawson IMMCO DIAGNOSTICS, INC. 9870 Hollingson Rd Clarence, NY 14031 |
| Product Code | MST |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-14 |
| Decision Date | 2017-07-28 |
| Summary: | summary |