The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Immulisa Enhanced Ama Igg Antibody Elisa; Immulisa Enhanced Ama Iga/igg/igm Antibody Elisa.
| Device ID | K163133 |
| 510k Number | K163133 |
| Device Name: | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA |
| Classification | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| 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 | DBM |
| CFR Regulation Number | 866.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-08 |
| Decision Date | 2017-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845714002526 | K163133 | 000 |
| 00845714002502 | K163133 | 000 |