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FDA 510(k)

CLEARVIEW HCG

K-Number: K910946 · 1991-04-01

ApplicantUnipath , Ltd.
Decision Date1991-04-01
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLEARVIEW HCG is the device name listed in this FDA 510(k) record. The listed applicant is Unipath , Ltd.. It received FDA 510(k) clearance on 1991-04-01 under 510(k) number K910946. 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 CLEARVIEW HCG?

CLEARVIEW HCG is a medical device that received FDA 510(k) clearance on 1991-04-01. The listed applicant is Unipath , Ltd.. The 510(k) number is K910946.

When did CLEARVIEW HCG receive FDA 510(k) clearance?

CLEARVIEW HCG received FDA 510(k) clearance on 1991-04-01, under 510(k) number K910946.

Who is the listed applicant for CLEARVIEW HCG?

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

What is the FDA product code for CLEARVIEW HCG?

The FDA product code for CLEARVIEW HCG is JHJ.

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Other records listing Unipath , Ltd. 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.

K061769E.P.T. CERTAINTY 1-STEP PREGNANCY TESTK060128CLEARBLUE EASY DIGITAL PREGNANCY TESTK051638INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBCK050930E.P.T. CERTAINTY PREGNANCY TESTK042280FACT PLUS ONE-STEP PREGNANCY TEST KITK041404CLEARBLUE EASY EASY READ PREGNANCY TEST

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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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