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FDA 510(k)

TOTAL IGE FAST TEST

K-Number: K834594 · 1984-02-10

ApplicantAllergenetics
Decision Date1984-02-10
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TOTAL IGE FAST TEST is the device name listed in this FDA 510(k) record. The listed applicant is Allergenetics. It received FDA 510(k) clearance on 1984-02-10 under 510(k) number K834594. 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 TOTAL IGE FAST TEST?

TOTAL IGE FAST TEST is a medical device that received FDA 510(k) clearance on 1984-02-10. The listed applicant is Allergenetics. The 510(k) number is K834594.

When did TOTAL IGE FAST TEST receive FDA 510(k) clearance?

TOTAL IGE FAST TEST received FDA 510(k) clearance on 1984-02-10, under 510(k) number K834594.

Who is the listed applicant for TOTAL IGE FAST TEST?

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

What is the FDA product code for TOTAL IGE FAST TEST?

The FDA product code for TOTAL IGE FAST TEST is DGC.

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Other records listing Allergenetics 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.

K851512ALLERGENETICS IGE FAST TESTK842970ALLERGENTICS TOTAL IGE/THEOPHYLLINEK842969ALLERGENETICS ALLER-SPECIFIC IGE SERUMK833418CHYMOFAST TESTK833419LABELED 125I ANTI-IGEK834244THEOFAST TEST KIT FOR QUANTITATIVE THEO

View all 8 devices →

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

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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