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FDA 510(k)

IGE-QUANT DIAGNOSTIC TEST KIT

K-Number: K831208 · 1983-05-09

ApplicantLeeco Diagnostics, Inc.
Decision Date1983-05-09
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IGE-QUANT DIAGNOSTIC TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Leeco Diagnostics, Inc.. It received FDA 510(k) clearance on 1983-05-09 under 510(k) number K831208. 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-QUANT DIAGNOSTIC TEST KIT?

IGE-QUANT DIAGNOSTIC TEST KIT is a medical device that received FDA 510(k) clearance on 1983-05-09. The listed applicant is Leeco Diagnostics, Inc.. The 510(k) number is K831208.

When did IGE-QUANT DIAGNOSTIC TEST KIT receive FDA 510(k) clearance?

IGE-QUANT DIAGNOSTIC TEST KIT received FDA 510(k) clearance on 1983-05-09, under 510(k) number K831208.

Who is the listed applicant for IGE-QUANT DIAGNOSTIC TEST KIT?

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

What is the FDA product code for IGE-QUANT DIAGNOSTIC TEST KIT?

The FDA product code for IGE-QUANT DIAGNOSTIC TEST KIT is DGC.

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Other records listing Leeco Diagnostics, Inc. as applicant

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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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