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FDA 510(k)

CEBTRIA DIGOXIN RIA

K-Number: K771255 · 1977-08-25

ApplicantUnion Carbide Corp.
Decision Date1977-08-25
Product CodeDON
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEBTRIA DIGOXIN RIA is the device name listed in this FDA 510(k) record. The listed applicant is Union Carbide Corp.. It received FDA 510(k) clearance on 1977-08-25 under 510(k) number K771255. 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 CEBTRIA DIGOXIN RIA?

CEBTRIA DIGOXIN RIA is a medical device that received FDA 510(k) clearance on 1977-08-25. The listed applicant is Union Carbide Corp.. The 510(k) number is K771255.

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

CEBTRIA DIGOXIN RIA received FDA 510(k) clearance on 1977-08-25, under 510(k) number K771255.

Who is the listed applicant for CEBTRIA DIGOXIN RIA?

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

What is the FDA product code for CEBTRIA DIGOXIN RIA?

The FDA product code for CEBTRIA DIGOXIN RIA is DON.

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Other records listing Union Carbide Corp. as applicant

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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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