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FDA 510(k)

DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG

K-Number: K092283 · 2009-10-21

ApplicantSiemens Healthcare Diagnostics
Decision Date2009-10-21
Product CodeDFZ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2009-10-21 under 510(k) number K092283. The device is classified under product code DFZ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG?

DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG is a medical device that received FDA 510(k) clearance on 2009-10-21. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K092283.

When did DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG receive FDA 510(k) clearance?

DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG received FDA 510(k) clearance on 2009-10-21, under 510(k) number K092283.

Who is the listed applicant for DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG?

The FDA 510(k) record lists Siemens Healthcare Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG?

The FDA product code for DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG is DFZ.

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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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