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FDA 510(k)

EARLY IN HOME PREGNANCY TEST

K-Number: K832599 · 1983-09-20

ApplicantWarner-Lambert Co.
Decision Date1983-09-20
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EARLY IN HOME PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Warner-Lambert Co.. It received FDA 510(k) clearance on 1983-09-20 under 510(k) number K832599. 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 EARLY IN HOME PREGNANCY TEST?

EARLY IN HOME PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1983-09-20. The listed applicant is Warner-Lambert Co.. The 510(k) number is K832599.

When did EARLY IN HOME PREGNANCY TEST receive FDA 510(k) clearance?

EARLY IN HOME PREGNANCY TEST received FDA 510(k) clearance on 1983-09-20, under 510(k) number K832599.

Who is the listed applicant for EARLY IN HOME PREGNANCY TEST?

The FDA 510(k) record lists Warner-Lambert Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EARLY IN HOME PREGNANCY TEST?

The FDA product code for EARLY IN HOME PREGNANCY TEST is JHJ.

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Other records listing Warner-Lambert 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.

K024160NEOSPORIN SCAR SOLUTIONK893452EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAMK870584O.P.T.(TM) OVULATION PREDICTION TESTK861510MULTILUMEN VIAPIC CENTRAL LINE CATHETERK852967GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISKK852689GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK

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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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