AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin— 510(k) K172461
Substantially EquivalentAesku.Diagnostics GmbH & Co. KG
FDA 510(k) clearance K172461 for AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin, Substantially Equivalent on 2018-03-23. Applicant: Aesku.Diagnostics GmbH & Co. KG. Device class: 2.
Clearance details
- Applicant
- Aesku.Diagnostics GmbH & Co. KG
- Product code
- Code MOB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wendelsheim, DE
Recent devices under product code MOB
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- K172582 — EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern
- K173792 — EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
- K161258 — NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
More clearances from Aesku.Diagnostics GmbH & Co. KG
view allData sourced from openFDA. This site is unofficial and independent of the FDA.