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FDA 510(k)

HEPARIN MANAGEMENT TEST CARD; HMT CARD

K-Number: K943283 · 1995-05-10

ApplicantCardiovascular Diagnostics, Inc.
Decision Date1995-05-10
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEPARIN MANAGEMENT TEST CARD; HMT 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 1995-05-10 under 510(k) number K943283. 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 HEPARIN MANAGEMENT TEST CARD; HMT CARD?

HEPARIN MANAGEMENT TEST CARD; HMT CARD is a medical device that received FDA 510(k) clearance on 1995-05-10. The listed applicant is Cardiovascular Diagnostics, Inc.. The 510(k) number is K943283.

When did HEPARIN MANAGEMENT TEST CARD; HMT CARD receive FDA 510(k) clearance?

HEPARIN MANAGEMENT TEST CARD; HMT CARD received FDA 510(k) clearance on 1995-05-10, under 510(k) number K943283.

Who is the listed applicant for HEPARIN MANAGEMENT TEST CARD; HMT 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 HEPARIN MANAGEMENT TEST CARD; HMT CARD?

The FDA product code for HEPARIN MANAGEMENT TEST CARD; HMT CARD is KFF.

Related Clinical Trials

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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 TESTK990566TAS ANALYZER, MODEL 1009K981206TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)

View all 13 devices →

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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