The following data is part of a premarket notification filed by Euroimmun Us Llc with the FDA for Euroimmun Pr3 Elisa Kit. Euroimmun Mpo Elisa Kit..
| Device ID | K060700 |
| 510k Number | K060700 |
| Device Name: | EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT. |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | EUROIMMUN US LLC TEK CAMPUS OF MORRIS COUNTY 429 ROCKAWAY VALLEY RD. U.1200 Boonton Twp, NJ 07005 |
| Contact | Kathryn Kohl |
| Correspondent | Kathryn Kohl EUROIMMUN US LLC TEK CAMPUS OF MORRIS COUNTY 429 ROCKAWAY VALLEY RD. U.1200 Boonton Twp, NJ 07005 |
| Product Code | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-15 |
| Decision Date | 2006-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016026761 | K060700 | 000 |