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FDA 510(k)

AESKULSKA BETA2-GLYCO-A

K-Number: K062217 · 2006-12-13

ApplicantAesku, Inc.
Decision Date2006-12-13
Product CodeMSV
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AESKULSKA BETA2-GLYCO-A is the device name listed in this FDA 510(k) record. The listed applicant is Aesku, Inc.. It received FDA 510(k) clearance on 2006-12-13 under 510(k) number K062217. The device is classified under product code MSV. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AESKULSKA BETA2-GLYCO-A?

AESKULSKA BETA2-GLYCO-A is a medical device that received FDA 510(k) clearance on 2006-12-13. The listed applicant is Aesku, Inc.. The 510(k) number is K062217.

When did AESKULSKA BETA2-GLYCO-A receive FDA 510(k) clearance?

AESKULSKA BETA2-GLYCO-A received FDA 510(k) clearance on 2006-12-13, under 510(k) number K062217.

Who is the listed applicant for AESKULSKA BETA2-GLYCO-A?

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 AESKULSKA BETA2-GLYCO-A?

The FDA product code for AESKULSKA BETA2-GLYCO-A is MSV.

Related Clinical Trials

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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.

K051492AESKULISA ASCA AK042644AESKULISA TTG A AND AESKULISA TTG GK040953AESKULISA ANA HEP-2K040463AESKULISA CARDIOLIPIN AGMK032469AESKULISA ANA 8PRO

Related Devices (Code: MSV)

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.

K243979Aptiva APS IgA ReagentInova Diagnostics, Inc.K181329EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA ImmunoassayPhadia ABK162788ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISAImmco Diagnostics, Inc.K112414ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAYPhadia US, Inc.K091556HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLSInstrumentation Laboratory COK092757THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCRThera-Test Laboratories, 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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