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FDA 510(k)

ENOXAPARIN TEST CARD

K-Number: K013305 · 2002-08-23

ApplicantCardiovascular Diagnostics, Inc.
Decision Date2002-08-23
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ENOXAPARIN TEST CARD 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 2002-08-23 under 510(k) number K013305. The device is classified under product code KFF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENOXAPARIN TEST CARD?

ENOXAPARIN TEST CARD is a medical device that received FDA 510(k) clearance on 2002-08-23. The listed applicant is Cardiovascular Diagnostics, Inc.. The 510(k) number is K013305.

When did ENOXAPARIN TEST CARD receive FDA 510(k) clearance?

ENOXAPARIN TEST CARD received FDA 510(k) clearance on 2002-08-23, under 510(k) number K013305.

Who is the listed applicant for ENOXAPARIN TEST CARD?

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 ENOXAPARIN TEST CARD?

The FDA product code for ENOXAPARIN TEST CARD is KFF.

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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.

K994194(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINTK994159HMP CONTROLS (TAS) RAPIDPOINTK993519RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TESTK990566TAS ANALYZER, MODEL 1009K981206TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)K981178THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS

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Related Devices (Code: KFF)

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.

K260214STA® - Liquid Anti-XaDiagnostica Stago, Inc.K213464HemosIL Liquid Anti-XaInstrumentation Laboratory COK162540INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW ControlsSiemens Healthcare Diagnostics Prodcts GmbHK111822STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWHDiagnostica Stago, Inc.K090209HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLSInstrumentation Laboratory COK050367BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6Hyphen Biomed

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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