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FDA 510(k)

AESKULISA TTG A AND AESKULISA TTG G

K-Number: K042644 · 2005-06-01

ApplicantAesku, Inc.
Decision Date2005-06-01
Product CodeMVM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AESKULISA TTG A AND AESKULISA TTG G is the device name listed in this FDA 510(k) record. The listed applicant is Aesku, Inc.. It received FDA 510(k) clearance on 2005-06-01 under 510(k) number K042644. The device is classified under product code MVM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AESKULISA TTG A AND AESKULISA TTG G?

AESKULISA TTG A AND AESKULISA TTG G is a medical device that received FDA 510(k) clearance on 2005-06-01. The listed applicant is Aesku, Inc.. The 510(k) number is K042644.

When did AESKULISA TTG A AND AESKULISA TTG G receive FDA 510(k) clearance?

AESKULISA TTG A AND AESKULISA TTG G received FDA 510(k) clearance on 2005-06-01, under 510(k) number K042644.

Who is the listed applicant for AESKULISA TTG A AND AESKULISA TTG G?

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

What is the FDA product code for AESKULISA TTG A AND AESKULISA TTG G?

The FDA product code for AESKULISA TTG A AND AESKULISA TTG G is MVM.

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Other records listing Aesku, Inc. 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.

K062217AESKULSKA BETA2-GLYCO-AK051492AESKULISA ASCA AK040953AESKULISA ANA HEP-2K040463AESKULISA CARDIOLIPIN AGMK032469AESKULISA ANA 8PRO

Related Devices (Code: MVM)

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.

K200230Aptiva Celiac Disease IgG ReagentInova Diagnostics, Inc.K193604Aptiva Celiac Disease IgA ReagentInova Diagnostics, Inc.K181871EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG ImmunoassayPhadia ABK183313EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)Euroimmun Us, Inc.K123713IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISAImmco Diagnostics, Inc.K130053BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BIBio-Rad Laboratories, Inc.

Official Source

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

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