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FDA 510(k)

DAC-CEL T3 UPTAKE

K-Number: K810212 · 1981-02-10

ApplicantBurroughs Wellcome Co.
Decision Date1981-02-10
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DAC-CEL T3 UPTAKE 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 1981-02-10 under 510(k) number K810212. The device is classified under product code KHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAC-CEL T3 UPTAKE?

DAC-CEL T3 UPTAKE is a medical device that received FDA 510(k) clearance on 1981-02-10. The listed applicant is Burroughs Wellcome Co.. The 510(k) number is K810212.

When did DAC-CEL T3 UPTAKE receive FDA 510(k) clearance?

DAC-CEL T3 UPTAKE received FDA 510(k) clearance on 1981-02-10, under 510(k) number K810212.

Who is the listed applicant for DAC-CEL T3 UPTAKE?

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 T3 UPTAKE?

The FDA product code for DAC-CEL T3 UPTAKE is KHQ.

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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 DIAGNATALK810213DAC-CEL TSHK791231DAC-CEL T4

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Related Devices (Code: KHQ)

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.

K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.K980088T-UPTAKE MICROPLATE EIAMonobindK970539CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.K964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)Johnson & Johnson Clinical Diagnostics, Inc.K961488ELECSYS T-UPTAKE ASSAYBoehringer Mannheim Corp.K954807CEDIA T UPTAKE ASSAYBoehringer Mannheim Corp.

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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