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FDA 510(k)

DAC-CEL HCG

K-Number: K810215 · 1981-04-17

ApplicantBurroughs Wellcome Co.
Decision Date1981-04-17
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DAC-CEL HCG 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 1981-04-17 under 510(k) number K810215. 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 HCG?

DAC-CEL HCG is a medical device that received FDA 510(k) clearance on 1981-04-17. The listed applicant is Burroughs Wellcome Co.. The 510(k) number is K810215.

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

DAC-CEL HCG received FDA 510(k) clearance on 1981-04-17, under 510(k) number K810215.

Who is the listed applicant for DAC-CEL HCG?

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 HCG?

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

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-CELK810214DAC-CEL DIAGNATALK810213DAC-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.

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. Co., Ltd.

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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