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FDA 510(k)

DAC-CEL DIAGNATAL

K-Number: K810214 · 1981-03-06

ApplicantBurroughs Wellcome Co.
Decision Date1981-03-06
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DAC-CEL DIAGNATAL 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 1981-03-06 under 510(k) number K810214. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAC-CEL DIAGNATAL?

DAC-CEL DIAGNATAL is a medical device that received FDA 510(k) clearance on 1981-03-06. The listed applicant is Burroughs Wellcome Co.. The 510(k) number is K810214.

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

DAC-CEL DIAGNATAL received FDA 510(k) clearance on 1981-03-06, under 510(k) number K810214.

Who is the listed applicant for DAC-CEL DIAGNATAL?

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 DIAGNATAL?

The FDA product code for DAC-CEL DIAGNATAL is JHI.

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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 HCGK810213DAC-CEL TSHK810212DAC-CEL T3 UPTAKEK791231DAC-CEL T4

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Related Devices (Code: JHI)

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.

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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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