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FDA 510(k)

DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)

K-Number: K070552 · 2007-04-30

ApplicantDade Behring, Inc.
Decision Date2007-04-30
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR) 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 2007-04-30 under 510(k) number K070552. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)?

DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR) is a medical device that received FDA 510(k) clearance on 2007-04-30. The listed applicant is Dade Behring, Inc.. The 510(k) number is K070552.

When did DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR) receive FDA 510(k) clearance?

DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR) received FDA 510(k) clearance on 2007-04-30, under 510(k) number K070552.

Who is the listed applicant for DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)?

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 FERRITIN FLEX REAGENT CARTRIDGE (FERR)?

The FDA product code for DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR) is JIT.

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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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