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FDA 510(k)

DIGOXIN KIT

K-Number: K823014 · 1982-11-01

ApplicantPcl-Ria, Inc.
Decision Date1982-11-01
Product CodeDPB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGOXIN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pcl-Ria, Inc.. It received FDA 510(k) clearance on 1982-11-01 under 510(k) number K823014. 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 DIGOXIN KIT?

DIGOXIN KIT is a medical device that received FDA 510(k) clearance on 1982-11-01. The listed applicant is Pcl-Ria, Inc.. The 510(k) number is K823014.

When did DIGOXIN KIT receive FDA 510(k) clearance?

DIGOXIN KIT received FDA 510(k) clearance on 1982-11-01, under 510(k) number K823014.

Who is the listed applicant for DIGOXIN KIT?

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

What is the FDA product code for DIGOXIN KIT?

The FDA product code for DIGOXIN KIT is DPB.

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Other records listing Pcl-Ria, Inc. 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.

K830526B-GCG SYSTEM BY RIAK822935THYROID STIMULATING HORMONEK822612T3 UPTAKE KITSK820886THYROXINE T4 KITK820358FOLLICLE STIMULATING HORMONE KITK820357LUTEINIZING HORMONE KIT

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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.K821811125I DIGOXIN RADIOIMMUNOASSAY KITCambridge Medical TechnologyK820274DIGOXIN RADIOIMMUNOASSAYAmerican Diagnostic Corp.K792153DIGOXIN RADIOIMMUNOASSAY SYSTEMRadioimmunoassay, Inc.K790602RIA, DIGNXIN-125-IEndocrine-Metabolic CenterK790540RIA 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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