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FDA 510(k)

GEMENI IGM ASSAY

K-Number: K800450 · 1980-04-24

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

Device Summary

GEMENI IGM 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 K800450. The device is classified under product code DAO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEMENI IGM ASSAY?

GEMENI IGM 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 K800450.

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

GEMENI IGM ASSAY received FDA 510(k) clearance on 1980-04-24, under 510(k) number K800450.

Who is the listed applicant for GEMENI IGM 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 IGM ASSAY?

The FDA product code for GEMENI IGM ASSAY is DAO.

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

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Related Devices (Code: DAO)

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.

K040431ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2Roche Diagnostics Corp.K982639SPIFE URINE IFEHelena LaboratoriesK955908BOEHRINGER MANNHEIM IGM ASSAYBoehringer Mannheim Corp.K850586SPQ TEST SYSTEM FOR IMMUNOGLOBULIN MApplications LabK841992MODIFICATION TO ACS CORONARY GUIDINGAdvanced Cardiovascular Systems, Inc.K812487IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGMDako Corp.

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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