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FDA 510(k)

AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin

K-Number: K172461 · 2018-03-23

ApplicantAesku.Diagnostics GmbH & Co. KG
Decision Date2018-03-23
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin is a medical device manufactured by Aesku.Diagnostics GmbH & Co. KG. It received FDA 510(k) clearance on 2018-03-23 under approval number K172461. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin?

AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin is a medical device that received FDA 510(k) clearance on 2018-03-23. It is manufactured by Aesku.Diagnostics GmbH & Co. KG. The 510(k) number is K172461.

When was AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin approved by the FDA?

AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin received FDA 510(k) clearance on 2018-03-23, under approval number K172461.

What company makes AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin?

AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin is manufactured by Aesku.Diagnostics GmbH & Co. KG.

What is the FDA product code for AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin?

The FDA product code for AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin is MOB.

Other Devices by Aesku.Diagnostics GmbH & Co. KG

K172348AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10

Related Devices (Code: MOB)

K161258NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitInova Diagnostics, Inc. K172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternEuroimmun Us, Inc. K173792EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayPhadia AB K243776Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)Zeus Scientific

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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