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FDA 510(k)

DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY

K-Number: K061338 · 2006-07-06

ApplicantDade Behring, Inc.
Decision Date2006-07-06
Product CodeCFN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2006-07-06 under 510(k) number K061338. The device is classified under product code CFN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY?

DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY is a medical device that received FDA 510(k) clearance on 2006-07-06. The listed applicant is Dade Behring, Inc.. The 510(k) number is K061338.

When did DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY receive FDA 510(k) clearance?

DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY received FDA 510(k) clearance on 2006-07-06, under 510(k) number K061338.

Who is the listed applicant for DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY?

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

What is the FDA product code for DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY?

The FDA product code for DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY is CFN.

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Related Devices (Code: CFN)

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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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