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FDA 510(k)

IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM

K-Number: K083080 · 2009-10-29

ApplicantSqi Diagnostics Systems
Decision Date2009-10-29
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM is the device name listed in this FDA 510(k) record. The listed applicant is Sqi Diagnostics Systems. It received FDA 510(k) clearance on 2009-10-29 under 510(k) number K083080. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM?

IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM is a medical device that received FDA 510(k) clearance on 2009-10-29. The listed applicant is Sqi Diagnostics Systems. The 510(k) number is K083080.

When did IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM receive FDA 510(k) clearance?

IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM received FDA 510(k) clearance on 2009-10-29, under 510(k) number K083080.

Who is the listed applicant for IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM?

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

What is the FDA product code for IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM?

The FDA product code for IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM is DHR.

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Other records listing Sqi Diagnostics Systems 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.

K102490IGX PLEX CELIAC QUALITATIVE ASSAY

Related Devices (Code: DHR)

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.

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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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