The following data is part of a premarket notification filed by Euroimmun Us Inc with the FDA for Euroimmun Anti-pr3-hn-hr Elisa (igg).
| Device ID | K082130 |
| 510k Number | K082130 |
| Device Name: | EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG) |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | EUROIMMUN US INC 95 WASHINGTON ST Morristown, NJ 07960 |
| Contact | Kathryn Kohl |
| Correspondent | Kathryn Kohl EUROIMMUN US INC 95 WASHINGTON ST Morristown, NJ 07960 |
| Product Code | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-29 |
| Decision Date | 2009-04-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016026754 | K082130 | 000 |