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FDA 510(k)

COAG-1 PT-NC TEST CARD

K-Number: K904325 · 1991-01-25

ApplicantCardiovascular Diagnostic Services
Decision Date1991-01-25
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAG-1 PT-NC 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 1991-01-25 under 510(k) number K904325. 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 COAG-1 PT-NC TEST CARD?

COAG-1 PT-NC TEST CARD is a medical device that received FDA 510(k) clearance on 1991-01-25. The listed applicant is Cardiovascular Diagnostic Services. The 510(k) number is K904325.

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

COAG-1 PT-NC TEST CARD received FDA 510(k) clearance on 1991-01-25, under 510(k) number K904325.

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

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

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 ANALYZERK903019MODIFIED COAG-1 PT 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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