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FDA 510(k)

DIMENSION VISTA FLEX REAGENT CARTRIDGES

K-Number: K061655 · 2006-07-10

ApplicantDade Behring, Inc.
Decision Date2006-07-10
Product CodeLDP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIMENSION VISTA FLEX REAGENT CARTRIDGES 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 2006-07-10 under 510(k) number K061655. The device is classified under product code LDP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION VISTA FLEX REAGENT CARTRIDGES?

DIMENSION VISTA FLEX REAGENT CARTRIDGES is a medical device that received FDA 510(k) clearance on 2006-07-10. The listed applicant is Dade Behring, Inc.. The 510(k) number is K061655.

When did DIMENSION VISTA FLEX REAGENT CARTRIDGES receive FDA 510(k) clearance?

DIMENSION VISTA FLEX REAGENT CARTRIDGES received FDA 510(k) clearance on 2006-07-10, under 510(k) number K061655.

Who is the listed applicant for DIMENSION VISTA FLEX REAGENT CARTRIDGES?

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 FLEX REAGENT CARTRIDGES?

The FDA product code for DIMENSION VISTA FLEX REAGENT CARTRIDGES is LDP.

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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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