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FDA 510(k)

TAS ANALYZER, MODEL 1009

K-Number: K990566 · 1999-05-14

ApplicantCardiovascular Diagnostics, Inc.
Decision Date1999-05-14
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TAS ANALYZER, MODEL 1009 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Diagnostics, Inc.. It received FDA 510(k) clearance on 1999-05-14 under 510(k) number K990566. 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 TAS ANALYZER, MODEL 1009?

TAS ANALYZER, MODEL 1009 is a medical device that received FDA 510(k) clearance on 1999-05-14. The listed applicant is Cardiovascular Diagnostics, Inc.. The 510(k) number is K990566.

When did TAS ANALYZER, MODEL 1009 receive FDA 510(k) clearance?

TAS ANALYZER, MODEL 1009 received FDA 510(k) clearance on 1999-05-14, under 510(k) number K990566.

Who is the listed applicant for TAS ANALYZER, MODEL 1009?

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

What is the FDA product code for TAS ANALYZER, MODEL 1009?

The FDA product code for TAS ANALYZER, MODEL 1009 is JPA.

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Other records listing Cardiovascular Diagnostics, Inc. 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.

K013305ENOXAPARIN TEST CARDK994194(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINTK994159HMP CONTROLS (TAS) RAPIDPOINTK993519RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TESTK981206TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)K981178THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS

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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

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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