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FDA 510(k)

ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY

K-Number: K031756 · 2003-06-25

ApplicantRoche Diagnostics Corp.
Decision Date2003-06-25
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2003-06-25 under 510(k) number K031756. The device is classified under product code CGN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY?

ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY is a medical device that received FDA 510(k) clearance on 2003-06-25. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K031756.

When did ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY receive FDA 510(k) clearance?

ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY received FDA 510(k) clearance on 2003-06-25, under 510(k) number K031756.

Who is the listed applicant for ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY?

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

What is the FDA product code for ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY?

The FDA product code for ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY is CGN.

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Other records listing Roche Diagnostics Corp. as applicant

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K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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Related Devices (Code: CGN)

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.

K233060Elecsys Folate IIIRoche DiagnosticsK223590Access Folate AssayBeckman Coulter, Inc.K192586LIAISON® FolateDiaSorin, Inc.K172201Atellica IM Folate AssaySiemens Healthcare Diagnostics, Inc.K161646Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control SetDiazyme LaboratoriesK103716ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSETRoche Diagnostics

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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