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FDA 510(k)

THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS

K-Number: K062128 · 2006-08-21

ApplicantDade Behring, Inc.
Decision Date2006-08-21
Product CodeJHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS 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 2006-08-21 under 510(k) number K062128. The device is classified under product code JHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS?

THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS is a medical device that received FDA 510(k) clearance on 2006-08-21. The listed applicant is Dade Behring, Inc.. The 510(k) number is K062128.

When did THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS receive FDA 510(k) clearance?

THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS received FDA 510(k) clearance on 2006-08-21, under 510(k) number K062128.

Who is the listed applicant for THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS?

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 THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS?

The FDA product code for THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS is JHS.

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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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