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FDA 510(k)

IVD TECHNOLOGIES ACHRAB TEST KIT

K-Number: K091468 · 2009-11-20

ApplicantIvd Technologies
Decision Date2009-11-20
Product CodeNST
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IVD TECHNOLOGIES ACHRAB TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Ivd Technologies. It received FDA 510(k) clearance on 2009-11-20 under 510(k) number K091468. The device is classified under product code NST. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IVD TECHNOLOGIES ACHRAB TEST KIT?

IVD TECHNOLOGIES ACHRAB TEST KIT is a medical device that received FDA 510(k) clearance on 2009-11-20. The listed applicant is Ivd Technologies. The 510(k) number is K091468.

When did IVD TECHNOLOGIES ACHRAB TEST KIT receive FDA 510(k) clearance?

IVD TECHNOLOGIES ACHRAB TEST KIT received FDA 510(k) clearance on 2009-11-20, under 510(k) number K091468.

Who is the listed applicant for IVD TECHNOLOGIES ACHRAB TEST KIT?

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

What is the FDA product code for IVD TECHNOLOGIES ACHRAB TEST KIT?

The FDA product code for IVD TECHNOLOGIES ACHRAB TEST KIT is NST.

Related Clinical Trials

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Related Devices (Code: NST)

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.

K080523KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KITKronus Market Development Associates, Inc.K051144ACETYLCHOLINE RECEPTOR AB (ARAB)RRAIbl-Hamburg GmbHK042248KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KITKronus Market Development Associates, 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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