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FDA 510(k)

IGE RADIOIMMUNOASSAY KIT

K-Number: K831377 · 1983-06-02

ApplicantAmerican Diagnostic Corp.
Decision Date1983-06-02
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IGE RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Diagnostic Corp.. It received FDA 510(k) clearance on 1983-06-02 under 510(k) number K831377. 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 IGE RADIOIMMUNOASSAY KIT?

IGE RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1983-06-02. The listed applicant is American Diagnostic Corp.. The 510(k) number is K831377.

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

IGE RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1983-06-02, under 510(k) number K831377.

Who is the listed applicant for IGE RADIOIMMUNOASSAY KIT?

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

What is the FDA product code for IGE RADIOIMMUNOASSAY KIT?

The FDA product code for IGE RADIOIMMUNOASSAY KIT is DGC.

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Other records listing American Diagnostic Corp. 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.

K162589Adscope 658 Electronic StethoscopeK093495OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITSK060321ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BKK012304ADC 656 ELECTRONIC STETHOSCOPEK962655ANEROID AND MERCURIAL SPHYGMOMANOMETERSK940686ELECTRONIC THERMOMETERS

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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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