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FDA 510(k)

RIA, DIGNXIN-125-I

K-Number: K790602 · 1979-07-30

ApplicantEndocrine-Metabolic Center
Decision Date1979-07-30
Product CodeDPB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RIA, DIGNXIN-125-I is the device name listed in this FDA 510(k) record. The listed applicant is Endocrine-Metabolic Center. It received FDA 510(k) clearance on 1979-07-30 under 510(k) number K790602. The device is classified under product code DPB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIA, DIGNXIN-125-I?

RIA, DIGNXIN-125-I is a medical device that received FDA 510(k) clearance on 1979-07-30. The listed applicant is Endocrine-Metabolic Center. The 510(k) number is K790602.

When did RIA, DIGNXIN-125-I receive FDA 510(k) clearance?

RIA, DIGNXIN-125-I received FDA 510(k) clearance on 1979-07-30, under 510(k) number K790602.

Who is the listed applicant for RIA, DIGNXIN-125-I?

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

What is the FDA product code for RIA, DIGNXIN-125-I?

The FDA product code for RIA, DIGNXIN-125-I is DPB.

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Other records listing Endocrine-Metabolic Center as applicant

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K821131RADIOIMMUNOASSAY PARATHYROID HORMONE MIDK811993RADIOIMMUNOASSAY, FOLLICLE STIMULATINGK811994RADIOIMMUNOASSAY LUTEINIZING HORMONEK810948RADIOIMMUNOASSAY THYROID STIM. HORM. KITK810351RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIEK800188EMC-M-180, T3 UPTAKE - 100 TUBES

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Related Devices (Code: DPB)

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.

K853021OPTIMATE DIGOXIN TESTMiles Laboratories, Inc.K823014DIGOXIN KITPcl-Ria, Inc.K821811125I DIGOXIN RADIOIMMUNOASSAY KITCambridge Medical TechnologyK820274DIGOXIN RADIOIMMUNOASSAYAmerican Diagnostic Corp.K792153DIGOXIN RADIOIMMUNOASSAY SYSTEMRadioimmunoassay, Inc.K790540RIA TEST KIT, CENTRIA DIGOXINVentrex Laboratories, 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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