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FDA 510(k)

EDL ONE-STAGE PROTHROMBIN TIME REAGENT

K-Number: K891370 · 1989-04-21

ApplicantElite Diagnostic , Ltd.
Decision Date1989-04-21
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EDL ONE-STAGE PROTHROMBIN TIME REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Elite Diagnostic , Ltd.. It received FDA 510(k) clearance on 1989-04-21 under 510(k) number K891370. 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 EDL ONE-STAGE PROTHROMBIN TIME REAGENT?

EDL ONE-STAGE PROTHROMBIN TIME REAGENT is a medical device that received FDA 510(k) clearance on 1989-04-21. The listed applicant is Elite Diagnostic , Ltd.. The 510(k) number is K891370.

When did EDL ONE-STAGE PROTHROMBIN TIME REAGENT receive FDA 510(k) clearance?

EDL ONE-STAGE PROTHROMBIN TIME REAGENT received FDA 510(k) clearance on 1989-04-21, under 510(k) number K891370.

Who is the listed applicant for EDL ONE-STAGE PROTHROMBIN TIME REAGENT?

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

What is the FDA product code for EDL ONE-STAGE PROTHROMBIN TIME REAGENT?

The FDA product code for EDL ONE-STAGE PROTHROMBIN TIME REAGENT is GJS.

Related Clinical Trials

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.

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Other records listing Elite Diagnostic , Ltd. 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.

K890859EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIMEK891175EDL ABNORMAL COAGULATION CONTROLK891179EDL NORMAL COAGULATION CONTROLK890619EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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