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FDA 510(k)

ELECSYS RBC FOLATE HEMOLYZED REAGENT

K-Number: K051292 · 2005-06-17

ApplicantRoche Diagnostics Corp.
Decision Date2005-06-17
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS RBC FOLATE HEMOLYZED REAGENT 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 2005-06-17 under 510(k) number K051292. 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 ELECSYS RBC FOLATE HEMOLYZED REAGENT?

ELECSYS RBC FOLATE HEMOLYZED REAGENT is a medical device that received FDA 510(k) clearance on 2005-06-17. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K051292.

When did ELECSYS RBC FOLATE HEMOLYZED REAGENT receive FDA 510(k) clearance?

ELECSYS RBC FOLATE HEMOLYZED REAGENT received FDA 510(k) clearance on 2005-06-17, under 510(k) number K051292.

Who is the listed applicant for ELECSYS RBC FOLATE HEMOLYZED REAGENT?

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 ELECSYS RBC FOLATE HEMOLYZED REAGENT?

The FDA product code for ELECSYS RBC FOLATE HEMOLYZED REAGENT is CGN.

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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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