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FDA 510(k)

AESKULISA MPO, MODEL 30-7303US

K-Number: K091860 · 2010-02-23

ApplicantAesku Diagnostics
Decision Date2010-02-23
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AESKULISA MPO, MODEL 30-7303US is the device name listed in this FDA 510(k) record. The listed applicant is Aesku Diagnostics. It received FDA 510(k) clearance on 2010-02-23 under 510(k) number K091860. 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 AESKULISA MPO, MODEL 30-7303US?

AESKULISA MPO, MODEL 30-7303US is a medical device that received FDA 510(k) clearance on 2010-02-23. The listed applicant is Aesku Diagnostics. The 510(k) number is K091860.

When did AESKULISA MPO, MODEL 30-7303US receive FDA 510(k) clearance?

AESKULISA MPO, MODEL 30-7303US received FDA 510(k) clearance on 2010-02-23, under 510(k) number K091860.

Who is the listed applicant for AESKULISA MPO, MODEL 30-7303US?

The FDA 510(k) record lists Aesku Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AESKULISA MPO, MODEL 30-7303US?

The FDA product code for AESKULISA MPO, MODEL 30-7303US is MOB.

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Other records listing Aesku Diagnostics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K132082AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECKK120889AESKUSLIDES ANA HEP-2K091859AESKU PR3K081251MODIFICATION TO AESKULISA DS DNA GK081104AESKULISA ANA HEP-2, REF 30-7115USK052439AESKULISA GLIA A AND AESKULISA GLIA G

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Related Devices (Code: MOB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261466Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMZeus ScientificK243776Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)Zeus ScientificK172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternEuroimmun Us, Inc.K172461AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA FormalinAesku.Diagnostics GmbH & Co. KGK173792EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayPhadia ABK161258NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitInova Diagnostics, Inc.

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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