The following data is part of a premarket notification filed by Euroimmun Us Inc with the FDA for Euroimmun Anca Ifa Europlus Granulocyte Biochip Mosaic Test Systems.
| Device ID | K083850 |
| 510k Number | K083850 |
| Device Name: | EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS |
| 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 | 2008-12-24 |
| Decision Date | 2009-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016091288 | K083850 | 000 |
| 04049016040248 | K083850 | 000 |
| 04049016040255 | K083850 | 000 |
| 04049016040262 | K083850 | 000 |
| 04049016040279 | K083850 | 000 |
| 04049016040323 | K083850 | 000 |
| 04049016040330 | K083850 | 000 |
| 04049016040354 | K083850 | 000 |
| 04049016072423 | K083850 | 000 |
| 04049016072461 | K083850 | 000 |
| 04049016091240 | K083850 | 000 |
| 04049016091257 | K083850 | 000 |
| 04049016091264 | K083850 | 000 |
| 04049016159704 | K083850 | 000 |