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FDA 510(k)

TESTCORP CRP

K-Number: K831362 · 1983-05-27

ApplicantCatheter Technology Corp.
Decision Date1983-05-27
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TESTCORP CRP 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 1983-05-27 under 510(k) number K831362. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TESTCORP CRP?

TESTCORP CRP is a medical device that received FDA 510(k) clearance on 1983-05-27. The listed applicant is Catheter Technology Corp.. The 510(k) number is K831362.

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

TESTCORP CRP received FDA 510(k) clearance on 1983-05-27, under 510(k) number K831362.

Who is the listed applicant for TESTCORP CRP?

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 CRP?

The FDA product code for TESTCORP CRP is DCN.

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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: DCN)

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.

K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbHK221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group , Ltd.K172868Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein ControlsThe Binding Site Group , Ltd.K171498MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentMeso Scale Diagnostics, LLC

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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