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FDA 510(k)

TESTCORP ASO

K-Number: K831363 · 1983-05-16

ApplicantCatheter Technology Corp.
Decision Date1983-05-16
Product CodeGTQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TESTCORP ASO 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 1983-05-16 under 510(k) number K831363. The device is classified under product code GTQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TESTCORP ASO?

TESTCORP ASO is a medical device that received FDA 510(k) clearance on 1983-05-16. The listed applicant is Catheter Technology Corp.. The 510(k) number is K831363.

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

TESTCORP ASO received FDA 510(k) clearance on 1983-05-16, under 510(k) number K831363.

Who is the listed applicant for TESTCORP ASO?

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 ASO?

The FDA product code for TESTCORP ASO is GTQ.

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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: GTQ)

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.

K052645VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;Ortho-Clinical DiagnosticsK953437OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.K915742TURBIQUANT ASLBehring Diagnostics, Inc.K926236BECKMAN ANTI-STREPTOLYSIN O KITBeckman Instruments, Inc.K924247ACCUTEX ASO LATEX TESTJ.S. Medical Assoc.K922723TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROLSimplicity Diagnostics, 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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