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FDA 510(k)

HEMOCHRON RESPONSE

K-Number: K983475 · 1999-05-03

ApplicantInternational Technidyne Corp.
Decision Date1999-05-03
Product CodeKQG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCHRON RESPONSE 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 1999-05-03 under 510(k) number K983475. The device is classified under product code KQG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOCHRON RESPONSE?

HEMOCHRON RESPONSE is a medical device that received FDA 510(k) clearance on 1999-05-03. The listed applicant is International Technidyne Corp.. The 510(k) number is K983475.

When did HEMOCHRON RESPONSE receive FDA 510(k) clearance?

HEMOCHRON RESPONSE received FDA 510(k) clearance on 1999-05-03, under 510(k) number K983475.

Who is the listed applicant for HEMOCHRON RESPONSE?

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 RESPONSE?

The FDA product code for HEMOCHRON RESPONSE is KQG.

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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: KQG)

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.

K050821COAGCARE ANTICOAGULATION MANAGEMENT SYSTEMZycareK021976FIBRON-1, FIBRON-4, QUIKCOAG, FIBRONVital Scientific N.V.K992130PACIFIC HEMOSTASIS THROMBOSCREEN 400CPacific HemostasisK991321PACIFIC HEMOSTASIS THROMBOSCREEN 200Pacific HemostasisK902614ELVI 828 DIGICLOT MULTISCANLogos Scientific, Inc.K900685CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZERTexas Intl. Laboratories, 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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