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FDA 510(k)

COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM

K-Number: K050821 · 2005-08-16

ApplicantZycare
Decision Date2005-08-16
Product CodeKQG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zycare. It received FDA 510(k) clearance on 2005-08-16 under 510(k) number K050821. 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 COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM?

COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2005-08-16. The listed applicant is Zycare. The 510(k) number is K050821.

When did COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM receive FDA 510(k) clearance?

COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM received FDA 510(k) clearance on 2005-08-16, under 510(k) number K050821.

Who is the listed applicant for COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM?

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

What is the FDA product code for COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM?

The FDA product code for COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM is KQG.

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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.

K021976FIBRON-1, FIBRON-4, QUIKCOAG, FIBRONVital Scientific N.V.K992130PACIFIC HEMOSTASIS THROMBOSCREEN 400CPacific HemostasisK991321PACIFIC HEMOSTASIS THROMBOSCREEN 200Pacific HemostasisK983475HEMOCHRON RESPONSEInternational Technidyne Corp.K902614ELVI 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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