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FDA 510(k)

ANSWER AT-HOME PREGNANCY TEST KIT

K-Number: K802660 · 1980-11-24

ApplicantArmkel, LLC
Decision Date1980-11-24
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ANSWER AT-HOME PREGNANCY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1980-11-24 under 510(k) number K802660. 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 ANSWER AT-HOME PREGNANCY TEST KIT?

ANSWER AT-HOME PREGNANCY TEST KIT is a medical device that received FDA 510(k) clearance on 1980-11-24. The listed applicant is Armkel, LLC. The 510(k) number is K802660.

When did ANSWER AT-HOME PREGNANCY TEST KIT receive FDA 510(k) clearance?

ANSWER AT-HOME PREGNANCY TEST KIT received FDA 510(k) clearance on 1980-11-24, under 510(k) number K802660.

Who is the listed applicant for ANSWER AT-HOME PREGNANCY TEST KIT?

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 ANSWER AT-HOME PREGNANCY TEST KIT?

The FDA product code for ANSWER AT-HOME PREGNANCY TEST KIT is JHJ.

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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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