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FDA 510(k)

HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS

K-Number: K923593 · 1992-09-22

ApplicantInternational Technidyne Corp.
Decision Date1992-09-22
Product CodeKQJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS 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 1992-09-22 under 510(k) number K923593. The device is classified under product code KQJ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS?

HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS is a medical device that received FDA 510(k) clearance on 1992-09-22. The listed applicant is International Technidyne Corp.. The 510(k) number is K923593.

When did HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS receive FDA 510(k) clearance?

HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS received FDA 510(k) clearance on 1992-09-22, under 510(k) number K923593.

Who is the listed applicant for HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS?

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/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS?

The FDA product code for HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS is KQJ.

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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

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Related Devices (Code: KQJ)

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.

K251968HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLInstrumentation Laboratory (IL) Co.K073367HEMOSIL FIBRINOGEN-CInstrumentation Laboratory COK050928DADE THROMBIN REAGENTDade Behring, Inc.K971858SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)Sigma Diagnostics, Inc.K970189FIF TMPanbio, Inc.K965113N-ASSAY TIA FIBRINOGEN TEST KITCrestat 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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