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FDA 510(k)

GEMENI IGG ASSAY

K-Number: K800451 · 1980-04-24

ApplicantElectro-Nucleonics Laboratories, Inc.
Decision Date1980-04-24
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GEMENI IGG ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics Laboratories, Inc.. It received FDA 510(k) clearance on 1980-04-24 under 510(k) number K800451. The device is classified under product code DEW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEMENI IGG ASSAY?

GEMENI IGG ASSAY is a medical device that received FDA 510(k) clearance on 1980-04-24. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K800451.

When did GEMENI IGG ASSAY receive FDA 510(k) clearance?

GEMENI IGG ASSAY received FDA 510(k) clearance on 1980-04-24, under 510(k) number K800451.

Who is the listed applicant for GEMENI IGG ASSAY?

The FDA 510(k) record lists Electro-Nucleonics Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEMENI IGG ASSAY?

The FDA product code for GEMENI IGG ASSAY is DEW.

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Other records listing Electro-Nucleonics Laboratories, Inc. as applicant

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Related Devices (Code: DEW)

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K050113TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K040434ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K010617SPIFE IFE CALIBRATOR AND CONTROL KITHelena LaboratoriesK993928WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARDWako Chemicals USA, Inc.K993281K-ASSAY IGGKamiya Biomedical Co.K983221IGGAbbott Laboratories

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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