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)

PROTIME MICROCOAGULATION SYSTEM

K-Number: K961835 · 1997-03-12

ApplicantInternational Technidyne Corp.
Decision Date1997-03-12
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PROTIME MICROCOAGULATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is International Technidyne Corp.. It received FDA 510(k) clearance on 1997-03-12 under 510(k) number K961835. 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 PROTIME MICROCOAGULATION SYSTEM?

PROTIME MICROCOAGULATION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-03-12. The listed applicant is International Technidyne Corp.. The 510(k) number is K961835.

When did PROTIME MICROCOAGULATION SYSTEM receive FDA 510(k) clearance?

PROTIME MICROCOAGULATION SYSTEM received FDA 510(k) clearance on 1997-03-12, under 510(k) number K961835.

Who is the listed applicant for PROTIME MICROCOAGULATION SYSTEM?

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

What is the FDA product code for PROTIME MICROCOAGULATION SYSTEM?

The FDA product code for PROTIME MICROCOAGULATION SYSTEM 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 International Technidyne 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.

K120977DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MICK050016HEMOCHRON SIGNATURE ELITEK030818HEMOCHRON RESPONSE/SYSTEMK023561ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEMK020798HEMOCHRON JR. SIGNATURE +K010599PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE

View all 47 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.

↑