The following data is part of a premarket notification filed by Euroimmun Us Llc with the FDA for Euroimmun Anca Ifa Granulocyte Biochip Moscaic Igg Antibody In Human Serum.
| Device ID | K051489 |
| 510k Number | K051489 |
| Device Name: | EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | EUROIMMUN US LLC TEK CAMPUS OF MORRIS COUNTY 429 ROCKAWAY VALLEY RD. Boonton Twp, NJ 07005 |
| Contact | Kathryn Kohl |
| Correspondent | Kathryn Kohl EUROIMMUN US LLC TEK CAMPUS OF MORRIS COUNTY 429 ROCKAWAY VALLEY RD. 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 | 2005-06-06 |
| Decision Date | 2006-02-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016121473 | K051489 | 000 |
| 04049016038993 | K051489 | 000 |
| 04049016038986 | K051489 | 000 |
| 04049016038979 | K051489 | 000 |
| 04049016038962 | K051489 | 000 |
| 04049016038825 | K051489 | 000 |
| 04049016038818 | K051489 | 000 |
| 04049016038801 | K051489 | 000 |
| 04049016038795 | K051489 | 000 |
| 04049016038740 | K051489 | 000 |
| 04049016038733 | K051489 | 000 |
| 04049016038726 | K051489 | 000 |
| 04049016038719 | K051489 | 000 |
| 04049016039440 | K051489 | 000 |
| 04049016039457 | K051489 | 000 |
| 04049016039464 | K051489 | 000 |
| 04049016103233 | K051489 | 000 |
| 04049016090236 | K051489 | 000 |
| 04049016090229 | K051489 | 000 |
| 04049016090175 | K051489 | 000 |
| 04049016071808 | K051489 | 000 |
| 04049016071792 | K051489 | 000 |
| 04049016071686 | K051489 | 000 |
| 04049016040194 | K051489 | 000 |
| 04049016040187 | K051489 | 000 |
| 04049016040170 | K051489 | 000 |
| 04049016040163 | K051489 | 000 |
| 04049016039471 | K051489 | 000 |
| 04049016072102 | K051489 | 000 |