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FDA 510(k)

ADVIA Centaur Total IgE (tIgE)

K-Number: K193493 · 2020-01-15

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2020-01-15
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur Total IgE (tIgE) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-01-15 under approval number K193493. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA Centaur Total IgE (tIgE)?

ADVIA Centaur Total IgE (tIgE) is a medical device that received FDA 510(k) clearance on 2020-01-15. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K193493.

When was ADVIA Centaur Total IgE (tIgE) approved by the FDA?

ADVIA Centaur Total IgE (tIgE) received FDA 510(k) clearance on 2020-01-15, under approval number K193493.

What company makes ADVIA Centaur Total IgE (tIgE)?

ADVIA Centaur Total IgE (tIgE) is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for ADVIA Centaur Total IgE (tIgE)?

The FDA product code for ADVIA Centaur Total IgE (tIgE) is DGC.

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Related Devices (Code: DGC)

K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve ControlsPhadia AB K220178Total Immunoglobulin E (IgE)Beckman Coulter, Inc. K214068Quantia IgEBiokit, S.A. K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc.

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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