Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PROTHROMBIN TIME TEST CARD

K-Number: K954625 · 1996-03-11

ApplicantCardiovascular Diagnostics, Inc.
Decision Date1996-03-11
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PROTHROMBIN TIME TEST CARD is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-03-11 under 510(k) number K954625. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTHROMBIN TIME TEST CARD?

PROTHROMBIN TIME TEST CARD is a medical device that received FDA 510(k) clearance on 1996-03-11. The listed applicant is Cardiovascular Diagnostics, Inc.. The 510(k) number is K954625.

When did PROTHROMBIN TIME TEST CARD receive FDA 510(k) clearance?

PROTHROMBIN TIME TEST CARD received FDA 510(k) clearance on 1996-03-11, under 510(k) number K954625.

Who is the listed applicant for PROTHROMBIN TIME TEST CARD?

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

What is the FDA product code for PROTHROMBIN TIME TEST CARD?

The FDA product code for PROTHROMBIN TIME TEST CARD is GJS.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cardiovascular Diagnostics, Inc. 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.

K013305ENOXAPARIN TEST CARDK994194(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINTK994159HMP CONTROLS (TAS) RAPIDPOINTK993519RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TESTK990566TAS ANALYZER, MODEL 1009K981206TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)

View all 13 devices →

Related Devices (Code: GJS)

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.

K253188CoaguChek XS Plus SystemRoche DiagnosticsK251564microINR SystemIline Microsystems, S.L.K243543microINR SystemIline Microsystems, S.L.K230802Xprecia Prime Coagulation SystemUniversal Biosensors Pty, Ltd.K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott LaboratoriesK231711microINR SystemIline Microsystems, S.L.

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.

↑