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FDA 510(k)

V-TREND BETA-HCG DRY-SPOT TEST

K-Number: K875262 · 1988-02-02

ApplicantTexas Immunology, Inc.
Decision Date1988-02-02
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

V-TREND BETA-HCG DRY-SPOT TEST is the device name listed in this FDA 510(k) record. The listed applicant is Texas Immunology, Inc.. It received FDA 510(k) clearance on 1988-02-02 under 510(k) number K875262. 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 V-TREND BETA-HCG DRY-SPOT TEST?

V-TREND BETA-HCG DRY-SPOT TEST is a medical device that received FDA 510(k) clearance on 1988-02-02. The listed applicant is Texas Immunology, Inc.. The 510(k) number is K875262.

When did V-TREND BETA-HCG DRY-SPOT TEST receive FDA 510(k) clearance?

V-TREND BETA-HCG DRY-SPOT TEST received FDA 510(k) clearance on 1988-02-02, under 510(k) number K875262.

Who is the listed applicant for V-TREND BETA-HCG DRY-SPOT TEST?

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

What is the FDA product code for V-TREND BETA-HCG DRY-SPOT TEST?

The FDA product code for V-TREND BETA-HCG DRY-SPOT TEST is JHJ.

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Other records listing Texas Immunology, Inc. as applicant

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K991465DRUG STOPK980153DRUG CHECKK973208FIRST SIGNK972094TARGET CARDIAC TROPONIN I TESTK963680TARGET MYOGLOBIN TESTK912246TARGET MICROALBUMINURIA 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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