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FDA 510(k)

DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT

K-Number: K780475 · 1978-04-24

ApplicantBurroughs Wellcome Co.
Decision Date1978-04-24
Product CodeDON
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Burroughs Wellcome Co.. It received FDA 510(k) clearance on 1978-04-24 under 510(k) number K780475. 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 DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT?

DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1978-04-24. The listed applicant is Burroughs Wellcome Co.. The 510(k) number is K780475.

When did DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1978-04-24, under 510(k) number K780475.

Who is the listed applicant for DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT?

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

What is the FDA product code for DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT?

The FDA product code for DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT is DON.

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Other records listing Burroughs Wellcome Co. 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.

K820069WELLCOGEN GROUP BK813508SAC-CELK810215DAC-CEL HCGK810214DAC-CEL DIAGNATALK810212DAC-CEL T3 UPTAKEK810213DAC-CEL TSH

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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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