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FDA 510(k)

HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY

K-Number: K862083 · 1986-07-02

ApplicantHygeia Sciences
Decision Date1986-07-02
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Hygeia Sciences. It received FDA 510(k) clearance on 1986-07-02 under 510(k) number K862083. 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 HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY?

HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY is a medical device that received FDA 510(k) clearance on 1986-07-02. The listed applicant is Hygeia Sciences. The 510(k) number is K862083.

When did HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY receive FDA 510(k) clearance?

HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY received FDA 510(k) clearance on 1986-07-02, under 510(k) number K862083.

Who is the listed applicant for HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY?

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

What is the FDA product code for HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY?

The FDA product code for HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY is JHJ.

Related Clinical Trials

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Other records listing Hygeia Sciences 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.

K882192HYGEIA URINE PREGNANCY TESTK881064HYGEIA GC TESTK862133HYGEIA RAPID STREP A TEST

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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