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FDA 510(k)

MODIFIED COAG-1 PT TEST CARD

K-Number: K903019 · 1990-08-01

ApplicantCardiovascular Diagnostic Services
Decision Date1990-08-01
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MODIFIED COAG-1 PT TEST CARD is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Diagnostic Services. It received FDA 510(k) clearance on 1990-08-01 under 510(k) number K903019. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED COAG-1 PT TEST CARD?

MODIFIED COAG-1 PT TEST CARD is a medical device that received FDA 510(k) clearance on 1990-08-01. The listed applicant is Cardiovascular Diagnostic Services. The 510(k) number is K903019.

When did MODIFIED COAG-1 PT TEST CARD receive FDA 510(k) clearance?

MODIFIED COAG-1 PT TEST CARD received FDA 510(k) clearance on 1990-08-01, under 510(k) number K903019.

Who is the listed applicant for MODIFIED COAG-1 PT TEST CARD?

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

What is the FDA product code for MODIFIED COAG-1 PT TEST CARD?

The FDA product code for MODIFIED COAG-1 PT TEST CARD is GJS.

Related Clinical Trials

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Other records listing Cardiovascular Diagnostic Services 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.

K955843TAS PTONEK933092TAS ANALYZERK904325COAG-1 PT-NC TEST CARDK891015COAG-1 APTT TEST CARDK882444COAG-I ANALYZER, ALPHA MODELK882456COAG-I PT TEST CARD

View all 8 devices →

Related Devices (Code: GJS)

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.

K253188CoaguChek XS Plus SystemRoche DiagnosticsK251564microINR SystemIline Microsystems, S.L.K243543microINR SystemIline Microsystems, S.L.K230802Xprecia Prime Coagulation SystemUniversal Biosensors Pty, Ltd.K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott LaboratoriesK231711microINR SystemIline Microsystems, S.L.

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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