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FDA 510(k)

FACT* HOME PREGNANCY TEST

K-Number: K810581 · 1981-03-17

ApplicantOrtho Pharmaceutical Corp.
Decision Date1981-03-17
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FACT* HOME PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Pharmaceutical Corp.. It received FDA 510(k) clearance on 1981-03-17 under 510(k) number K810581. 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 FACT* HOME PREGNANCY TEST?

FACT* HOME PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1981-03-17. The listed applicant is Ortho Pharmaceutical Corp.. The 510(k) number is K810581.

When did FACT* HOME PREGNANCY TEST receive FDA 510(k) clearance?

FACT* HOME PREGNANCY TEST received FDA 510(k) clearance on 1981-03-17, under 510(k) number K810581.

Who is the listed applicant for FACT* HOME PREGNANCY TEST?

The FDA 510(k) record lists Ortho Pharmaceutical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FACT* HOME PREGNANCY TEST?

The FDA product code for FACT* HOME PREGNANCY TEST is JHJ.

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Other records listing Ortho Pharmaceutical Corp. 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.

K955648K-Y PERSONAL LUBRICANTK934516ADVANCE PREGNANCY TEST MODIFICATIONK914990ADVANCE(R) PREGNANCY TESTK893488PULSATILE PUMP FOR GONADORELIN ACETATEK881151MICROSCRAPEK800754NICKERSON'S MED. SELECTIVE CULTURE MEDIU

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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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