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FDA 510(k)

DIGOXIN RIABEAD DIAGNOSTIC KIT

K-Number: K803075 · 1980-12-22

ApplicantAbbott Laboratories
Decision Date1980-12-22
Product CodeDON
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGOXIN RIABEAD DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1980-12-22 under 510(k) number K803075. 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 RIABEAD DIAGNOSTIC KIT?

DIGOXIN RIABEAD DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1980-12-22. The listed applicant is Abbott Laboratories. The 510(k) number is K803075.

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

DIGOXIN RIABEAD DIAGNOSTIC KIT received FDA 510(k) clearance on 1980-12-22, under 510(k) number K803075.

Who is the listed applicant for DIGOXIN RIABEAD DIAGNOSTIC KIT?

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

What is the FDA product code for DIGOXIN RIABEAD DIAGNOSTIC KIT?

The FDA product code for DIGOXIN RIABEAD DIAGNOSTIC KIT is DON.

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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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