The following data is part of a premarket notification filed by Aesku.diagnostics with the FDA for Aeskulisa Mpo, Model 30-7303us.
Device ID | K091860 |
510k Number | K091860 |
Device Name: | AESKULISA MPO, MODEL 30-7303US |
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 | 2010-02-23 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847817018657 | K091860 | 000 |
04250289503556 | K091860 | 000 |
04250289501361 | K091860 | 000 |