The following data is part of a premarket notification filed by Aesku.diagnostics with the FDA for Aesku Pr3.
| Device ID | K091859 |
| 510k Number | K091859 |
| Device Name: | AESKU PR3 |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | AESKU.DIAGNOSTICS MIKROFORUM RING 2 Wendelsheim, Rheinland, DE D-55234 |
| Contact | Sascha Pfeiffer |
| Correspondent | Sascha Pfeiffer AESKU.DIAGNOSTICS MIKROFORUM RING 2 Wendelsheim, Rheinland, DE D-55234 |
| Product Code | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-19 |
| Decision Date | 2010-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817018695 | K091859 | 000 |
| 04250289503549 | K091859 | 000 |
| 04250289501354 | K091859 | 000 |