The following data is part of a premarket notification filed by Aesku.diagnostics Gmbh & Co. Kg with the FDA for Aeskuslides Anca Ethanol, Aeskuslides Anca Formalin.
| Device ID | K172461 |
| 510k Number | K172461 |
| Device Name: | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | Aesku.Diagnostics GmbH & Co. KG Mikro-Forum-Ring 2 Wendelsheim, DE 55234 |
| Contact | Sandra Reuter |
| Correspondent | Sandra Reuter Aesku.Diagnostics GmbH & Co. KG Mikro-Forum-Ring 2 Wendelsheim, DE 55234 |
| Product Code | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-14 |
| Decision Date | 2018-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250289510387 | K172461 | 000 |
| 04250289510370 | K172461 | 000 |
| 04250289510363 | K172461 | 000 |
| 04250289510356 | K172461 | 000 |