The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Elia Pr3s Immunoassay, Elia Mpos Immunoassay, Elia Gbm Immunoassay, Elia Anca/gbm Positive Control 100, Elia Anca/gbm Po.
| Device ID | K140225 |
| 510k Number | K140225 |
| Device Name: | ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | PHADIA US INC. MUNZINGER STRASSE 7 Freiburg Im Breisgau, DE 79111 |
| Contact | Martin Mann |
| Correspondent | Martin Mann PHADIA US INC. MUNZINGER STRASSE 7 Freiburg Im Breisgau, DE 79111 |
| Product Code | MOB |
| Subsequent Product Code | JJY |
| Subsequent Product Code | MVJ |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-29 |
| Decision Date | 2014-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066010823 | K140225 | 000 |
| 07333066010816 | K140225 | 000 |
| 07333066010670 | K140225 | 000 |
| 07333066013886 | K140225 | 000 |
| 07333066013831 | K140225 | 000 |