The following data is part of a premarket notification filed by Euroimmun Us, Inc. with the FDA for Euroimmun Ifa Granulocyte Mosaic™ Europattern And Euroimmun Europlus Granulocyte Mosaic™ Europattern.
| Device ID | K172582 |
| 510k Number | K172582 |
| Device Name: | EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern And EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | Euroimmun US, Inc. 1 Bloomfield Avenue Mountain Lakes, NJ 07046 |
| Contact | Michael A. Locke |
| Correspondent | Michael A. Locke Euroimmun US, Inc. 1 Bloomfield Avenue Mountain Lakes, NJ 07046 |
| Product Code | MOB |
| Subsequent Product Code | MVJ |
| Subsequent Product Code | PIV |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-28 |
| Decision Date | 2018-05-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016135975 | K172582 | 000 |
| 04049016108764 | K172582 | 000 |
| 04049016108832 | K172582 | 000 |
| 04049016108849 | K172582 | 000 |
| 04049016108856 | K172582 | 000 |
| 04049016108863 | K172582 | 000 |
| 04049016108931 | K172582 | 000 |
| 04049016108948 | K172582 | 000 |
| 04049016108955 | K172582 | 000 |
| 04049016108757 | K172582 | 000 |
| 04049016108740 | K172582 | 000 |
| 04049016108542 | K172582 | 000 |
| 04049016108559 | K172582 | 000 |
| 04049016108566 | K172582 | 000 |
| 04049016108634 | K172582 | 000 |
| 04049016108641 | K172582 | 000 |
| 04049016108658 | K172582 | 000 |
| 04049016108665 | K172582 | 000 |
| 04049016108733 | K172582 | 000 |
| 04049016108962 | K172582 | 000 |
| 04049016119920 | K172582 | 000 |
| 04049016135890 | K172582 | 000 |
| 04049016135906 | K172582 | 000 |
| 04049016135913 | K172582 | 000 |
| 04049016135920 | K172582 | 000 |
| 04049016135937 | K172582 | 000 |
| 04049016135944 | K172582 | 000 |
| 04049016135951 | K172582 | 000 |
| 04049016135968 | K172582 | 000 |
| 04049016135883 | K172582 | 000 |
| 04049016135876 | K172582 | 000 |
| 04049016121497 | K172582 | 000 |
| 04049016135807 | K172582 | 000 |
| 04049016135814 | K172582 | 000 |
| 04049016135821 | K172582 | 000 |
| 04049016135838 | K172582 | 000 |
| 04049016135845 | K172582 | 000 |
| 04049016135852 | K172582 | 000 |
| 04049016135869 | K172582 | 000 |
| 04049016108535 | K172582 | 000 |