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FDA 510(k)

TESTCORP PREG

K-Number: K831366 · 1983-06-02

ApplicantCatheter Technology Corp.
Decision Date1983-06-02
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TESTCORP PREG is the device name listed in this FDA 510(k) record. The listed applicant is Catheter Technology Corp.. It received FDA 510(k) clearance on 1983-06-02 under 510(k) number K831366. 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 TESTCORP PREG?

TESTCORP PREG is a medical device that received FDA 510(k) clearance on 1983-06-02. The listed applicant is Catheter Technology Corp.. The 510(k) number is K831366.

When did TESTCORP PREG receive FDA 510(k) clearance?

TESTCORP PREG received FDA 510(k) clearance on 1983-06-02, under 510(k) number K831366.

Who is the listed applicant for TESTCORP PREG?

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

What is the FDA product code for TESTCORP PREG?

The FDA product code for TESTCORP PREG is JHJ.

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Other records listing Catheter Technology Corp. 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.

K880571CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEMK871080PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERK871998GROSHONG CV CATHETER REPAIR KITK860256BRAWN AND GROSHONG CATHETERSK842577CATH-TECH POLYURETHANE UMBILICAL VESSK842147CATH-TECH CHOLANGIOGRAPHY CATHETER

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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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