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FDA 510(k)

DIGOXIN RIA ASSAY

K-Number: K810296 · 1981-02-19

ApplicantRia Diagnostics
Decision Date1981-02-19
Product CodeDON
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGOXIN RIA ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Ria Diagnostics. It received FDA 510(k) clearance on 1981-02-19 under 510(k) number K810296. The device is classified under product code DON. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGOXIN RIA ASSAY?

DIGOXIN RIA ASSAY is a medical device that received FDA 510(k) clearance on 1981-02-19. The listed applicant is Ria Diagnostics. The 510(k) number is K810296.

When did DIGOXIN RIA ASSAY receive FDA 510(k) clearance?

DIGOXIN RIA ASSAY received FDA 510(k) clearance on 1981-02-19, under 510(k) number K810296.

Who is the listed applicant for DIGOXIN RIA ASSAY?

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

What is the FDA product code for DIGOXIN RIA ASSAY?

The FDA product code for DIGOXIN RIA ASSAY is DON.

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Other records listing Ria Diagnostics 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.

K855033T-3 UPTAKE/RIASSAYK854798T-4 RIASSAYK852537T-3 RIASSAYK801691TSH RIASSAYK792062THEOPHYLLINE RIASSAYK780012ANTITHROMBIN III RIA

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Related Devices (Code: DON)

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.

K902861CIBA CORNING ACS DIGOXIN IMMUNOASSAYCiba Corning Diagnostics Corp.K881679CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAYCiba Corning Diagnostics Corp.K840461MAGIC 125I DIGOXIN RADIOIMMUNOASSAYCorning Medical & ScientificK830533PHASE II DIGOXIN RADIOIMMUNOASSAY KITMedical & Scientific Designs, Inc.K822053ZETAPHASE-DIGBiological & Diagnostic ProductsK821000ENZYMUNE-TEST DIGOXINIcl Scientific

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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