The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Immulisa Enhanced B2gp1 Iga Antibody Elisa, Immulisa Enhanced B2gp1 Igg Antibody Elisa, Immulisa Enhanced B2gp1 Igm Antibody Elisa, Immulisa Enhanced B2gp1 Iga/igg/igm Antibody Elisa.
| Device ID | K162788 |
| 510k Number | K162788 |
| Device Name: | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA |
| Classification | System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
| 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 | MSV |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-03 |
| Decision Date | 2017-06-19 |
| Summary: | summary |