The following data is part of a premarket notification filed by Euroimmun Us with the FDA for Ifa 40: Hep-20-10.
| Device ID | K131791 |
| 510k Number | K131791 |
| Device Name: | IFA 40: HEP-20-10 |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | EUROIMMUN US 1100 THE AMERICAN ROAD Morris Plains, NJ 07950 |
| Contact | Michael Locke |
| Correspondent | Michael Locke EUROIMMUN US 1100 THE AMERICAN ROAD Morris Plains, NJ 07950 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-18 |
| Decision Date | 2014-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016099055 | K131791 | 000 |
| 04049016099048 | K131791 | 000 |
| 04049016099031 | K131791 | 000 |
| 04049016099024 | K131791 | 000 |
| 04049016099017 | K131791 | 000 |