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FDA 510(k)

UCG-BETA STAT

K-Number: K802421 · 1980-10-23

ApplicantArmkel, LLC
Decision Date1980-10-23
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UCG-BETA STAT is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1980-10-23 under 510(k) number K802421. The device is classified under product code JHJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UCG-BETA STAT?

UCG-BETA STAT is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is Armkel, LLC. The 510(k) number is K802421.

When did UCG-BETA STAT receive FDA 510(k) clearance?

UCG-BETA STAT received FDA 510(k) clearance on 1980-10-23, under 510(k) number K802421.

Who is the listed applicant for UCG-BETA STAT?

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

What is the FDA product code for UCG-BETA STAT?

The FDA product code for UCG-BETA STAT is JHJ.

Other records listing Armkel, LLC 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.

K040866FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TESTK030258FIRST RESPONSE PREGNANCY TESTK023405TROJAN MINT TINGLE BRAND LATEX CONDOMSK013433TROJAN PASSION BERRY GELK013614TROJAN CRYSTAL CLEAR LIQUIDK001212TROJAN EXTRA LARGE LATEX CONDOM

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Related Devices (Code: JHJ)

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.

K972606PREGNACOL PREGNANCY TESTImmunostics Inc.,K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTTech-Co, Inc.K935863SAS(TM) DIRECT MONOCLONAL HCGSa Scientific, Inc.K926112ACCUTEX BETA-HCG TESTJ.S. Medical Assoc.K930609SAS(TM) MONOCLONAL HCG-SLIDESa Scientific, Inc.K920716DIRECT PREGNANCY TESTTech-Co, Inc.

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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