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FDA 510(k)

PREG/TEX PREGNANCY TEST

K-Number: K821387 · 1982-06-02

ApplicantTexas Immunology, Inc.
Decision Date1982-06-02
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PREG/TEX PREGNANCY 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 1982-06-02 under 510(k) number K821387. 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 PREG/TEX PREGNANCY TEST?

PREG/TEX PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1982-06-02. The listed applicant is Texas Immunology, Inc.. The 510(k) number is K821387.

When did PREG/TEX PREGNANCY TEST receive FDA 510(k) clearance?

PREG/TEX PREGNANCY TEST received FDA 510(k) clearance on 1982-06-02, under 510(k) number K821387.

Who is the listed applicant for PREG/TEX PREGNANCY 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 PREG/TEX PREGNANCY TEST?

The FDA product code for PREG/TEX PREGNANCY 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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