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FDA 510(k)

IMMUNETECH TOTAL IGE SYSTEM

K-Number: K032251 · 2003-12-19

ApplicantImmunetech Corporation
Decision Date2003-12-19
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNETECH TOTAL IGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Immunetech Corporation. It received FDA 510(k) clearance on 2003-12-19 under 510(k) number K032251. 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 IMMUNETECH TOTAL IGE SYSTEM?

IMMUNETECH TOTAL IGE SYSTEM is a medical device that received FDA 510(k) clearance on 2003-12-19. The listed applicant is Immunetech Corporation. The 510(k) number is K032251.

When did IMMUNETECH TOTAL IGE SYSTEM receive FDA 510(k) clearance?

IMMUNETECH TOTAL IGE SYSTEM received FDA 510(k) clearance on 2003-12-19, under 510(k) number K032251.

Who is the listed applicant for IMMUNETECH TOTAL IGE SYSTEM?

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

What is the FDA product code for IMMUNETECH TOTAL IGE SYSTEM?

The FDA product code for IMMUNETECH TOTAL IGE SYSTEM is DGC.

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Other records listing Immunetech Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061979MODIFICATION TO MYALLERGY TESTK021698MY ALLERGY TESTK020387MYALLERGYTEST SYSTEM

Related Devices (Code: DGC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc.K214068Quantia IgEBiokit, S.A.K220178Total Immunoglobulin E (IgE)Beckman Coulter, Inc.K193493ADVIA Centaur Total IgE (tIgE)Siemens Healthcare Diagnostics, Inc.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 ABK063425DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGHDade Behring, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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