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FDA 510(k)

UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST

K-Number: K851076 · 1985-05-10

ApplicantUnited Biotech, Inc.
Decision Date1985-05-10
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is United Biotech, Inc.. It received FDA 510(k) clearance on 1985-05-10 under 510(k) number K851076. 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 UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST?

UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1985-05-10. The listed applicant is United Biotech, Inc.. The 510(k) number is K851076.

When did UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST receive FDA 510(k) clearance?

UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST received FDA 510(k) clearance on 1985-05-10, under 510(k) number K851076.

Who is the listed applicant for UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST?

The FDA 510(k) record lists United Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST?

The FDA product code for UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST is JHI.

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Other records listing United Biotech, Inc. 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.

K981573UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVEK973154UBI MAGIWEL MARIJUANA METABOLITESK973692UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVEK973156UBI MAGIWEL COCAINE METABOLITESK973153UBI MAGIWEL AMPHETAMINE METABOLITESK973155UBI MAGIWEL OPIATE METABOLITES

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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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