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FDA 510(k)

AIA-PACK RBC FOLATE

K-Number: K091332 · 2009-10-02

ApplicantTosoh Bioscience, Inc.
Decision Date2009-10-02
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AIA-PACK RBC FOLATE is the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Bioscience, Inc.. It received FDA 510(k) clearance on 2009-10-02 under 510(k) number K091332. 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 AIA-PACK RBC FOLATE?

AIA-PACK RBC FOLATE is a medical device that received FDA 510(k) clearance on 2009-10-02. The listed applicant is Tosoh Bioscience, Inc.. The 510(k) number is K091332.

When did AIA-PACK RBC FOLATE receive FDA 510(k) clearance?

AIA-PACK RBC FOLATE received FDA 510(k) clearance on 2009-10-02, under 510(k) number K091332.

Who is the listed applicant for AIA-PACK RBC FOLATE?

The FDA 510(k) record lists Tosoh Bioscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIA-PACK RBC FOLATE?

The FDA product code for AIA-PACK RBC FOLATE is CGN.

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Other records listing Tosoh Bioscience, Inc. as applicant

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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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