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FDA 510(k)

COAG-1 APTT TEST CARD

K-Number: K891015 · 1989-05-22

ApplicantCardiovascular Diagnostic Services
Decision Date1989-05-22
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAG-1 APTT 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 1989-05-22 under 510(k) number K891015. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAG-1 APTT TEST CARD?

COAG-1 APTT TEST CARD is a medical device that received FDA 510(k) clearance on 1989-05-22. The listed applicant is Cardiovascular Diagnostic Services. The 510(k) number is K891015.

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

COAG-1 APTT TEST CARD received FDA 510(k) clearance on 1989-05-22, under 510(k) number K891015.

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

The FDA product code for COAG-1 APTT TEST CARD is GFO.

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 CARDK903019MODIFIED COAG-1 PT TEST CARDK882444COAG-I ANALYZER, ALPHA MODELK882456COAG-I PT TEST CARD

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Related Devices (Code: GFO)

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.

K253957HemosIL Silica Clotting TimeInstrumentation Laboratory (IL) Co.K193556Cryocheck Hex LAPrecision BiologicK160445HemosIL Silica Clotting TimeInstrumentation Laboratory COK053111STA-CEPHASCREEN KITDiagnostica Stago, Inc.K060688HEMOSIL SYNTHASILInstrumentation Laboratory COK050221HEMOSIL SILICA CLOTTING TIMEInstrumentation Laboratory CO

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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