The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Immuglo Hep-2 Elite Ifa.
| Device ID | K172745 |
| 510k Number | K172745 |
| Device Name: | ImmuGlo HEp-2 Elite IFA |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| 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 | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-12 |
| Decision Date | 2018-06-05 |
| Summary: | summary |