The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Immulisa Enhanced Rf Iga Antibody Elisa, Immulisa Enhanced Rf Igg Antibody Elisa, Immulisa Enhanced Rf Igm Antibody Elisa, Immulisa Enhanced Rf Antibody Screen Elisa.
| Device ID | K143736 |
| 510k Number | K143736 |
| Device Name: | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA |
| Classification | System, Test, Rheumatoid Factor |
| 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 | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-30 |
| Decision Date | 2015-09-23 |