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FDA 510(k)

HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION

K-Number: K930068 · 1993-09-02

ApplicantTechnidyne Corp.
Decision Date1993-09-02
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION is the device name listed in this FDA 510(k) record. The listed applicant is Technidyne Corp.. It received FDA 510(k) clearance on 1993-09-02 under 510(k) number K930068. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION?

HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION is a medical device that received FDA 510(k) clearance on 1993-09-02. The listed applicant is Technidyne Corp.. The 510(k) number is K930068.

When did HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION receive FDA 510(k) clearance?

HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION received FDA 510(k) clearance on 1993-09-02, under 510(k) number K930068.

Who is the listed applicant for HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION?

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

What is the FDA product code for HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION?

The FDA product code for HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION is JPA.

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.

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Other records listing 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.

K930235HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY

Related Devices (Code: JPA)

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.

K253658STA Satellite Max®Diagnostica Stago, Inc.K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemoneticsK243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics CorporationK232018Citrated: K, KH, RTH, FFHHaemonetics CorporationK233790ACL TOP 970 CLInstrumentation Laboratory

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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