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FDA 510(k)

125I-IGE RADIOIMMUNOASSAY KIT

K-Number: K801019 · 1980-05-20

ApplicantBio-Ria
Decision Date1980-05-20
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

125I-IGE RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Ria. It received FDA 510(k) clearance on 1980-05-20 under 510(k) number K801019. 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 125I-IGE RADIOIMMUNOASSAY KIT?

125I-IGE RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1980-05-20. The listed applicant is Bio-Ria. The 510(k) number is K801019.

When did 125I-IGE RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

125I-IGE RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1980-05-20, under 510(k) number K801019.

Who is the listed applicant for 125I-IGE RADIOIMMUNOASSAY KIT?

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

What is the FDA product code for 125I-IGE RADIOIMMUNOASSAY KIT?

The FDA product code for 125I-IGE RADIOIMMUNOASSAY KIT is DGC.

Related Clinical Trials

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Other records listing Bio-Ria 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.

K812901125I FERRITIN RADIOIMMUNOASSAY KIT

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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