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)

HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT

K-Number: K924637 · 1993-01-27

ApplicantInternational Technidyne Corp.
Decision Date1993-01-27
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT 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 1993-01-27 under 510(k) number K924637. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT?

HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT is a medical device that received FDA 510(k) clearance on 1993-01-27. The listed applicant is International Technidyne Corp.. The 510(k) number is K924637.

When did HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT receive FDA 510(k) clearance?

HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT received FDA 510(k) clearance on 1993-01-27, under 510(k) number K924637.

Who is the listed applicant for HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT?

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 HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT?

The FDA product code for HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT is GFO.

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: GFO)

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.

K253957HemosIL Silica Clotting TimeInstrumentation Laboratory (IL) Co.K193556Cryocheck Hex LAPrecision BiologicK160445HemosIL Silica Clotting TimeInstrumentation Laboratory COK053111STA-CEPHASCREEN KITDiagnostica Stago, Inc.K060688HEMOSIL SYNTHASILInstrumentation Laboratory COK050221HEMOSIL SILICA CLOTTING TIMEInstrumentation Laboratory CO

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.

↑