510(k) K172461
K172461 is an FDA 510(k) premarket notification submitted by Aesku.Diagnostics GmbH & Co. KG for the device "AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin". The FDA issued a decision of Substantially Equivalent on March 23, 2018. The device falls under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), a Class II device regulated under 21 CFR 866.5660. Aesku.Diagnostics GmbH & Co. KG has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 2018
- Date Received
- August 14, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
- Device Class
- Class II
- Regulation Number
- 866.5660
- Review Panel
- IM
- Submission Type