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FDA 510(k)

TAS PT-NCTEST CONTROLS

K-Number: K971748 · 1997-05-29

ApplicantCardiovascular Diagnostics, Inc.
Decision Date1997-05-29
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TAS PT-NCTEST CONTROLS 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 1997-05-29 under 510(k) number K971748. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TAS PT-NCTEST CONTROLS?

TAS PT-NCTEST CONTROLS is a medical device that received FDA 510(k) clearance on 1997-05-29. The listed applicant is Cardiovascular Diagnostics, Inc.. The 510(k) number is K971748.

When did TAS PT-NCTEST CONTROLS receive FDA 510(k) clearance?

TAS PT-NCTEST CONTROLS received FDA 510(k) clearance on 1997-05-29, under 510(k) number K971748.

Who is the listed applicant for TAS PT-NCTEST CONTROLS?

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 PT-NCTEST CONTROLS?

The FDA product code for TAS PT-NCTEST CONTROLS is GGN.

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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)

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Related Devices (Code: GGN)

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K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLCK163498VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLCK161316George King Coumadin PlasmaGeorge King Bio-Medical, Inc.K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLCK152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLCK150144VisuCon-F Low Fibrinogen Control PlasmaAffinity Biologicals, 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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