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FDA 510(k)

EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME

K-Number: K890859 · 1989-04-21

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

Device Summary

EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME 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 K890859. 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 EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME?

EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME 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 K890859.

When did EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME receive FDA 510(k) clearance?

EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME received FDA 510(k) clearance on 1989-04-21, under 510(k) number K890859.

Who is the listed applicant for EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME?

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 GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME?

The FDA product code for EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME is GFO.

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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.

K891370EDL ONE-STAGE PROTHROMBIN TIME REAGENTK891175EDL ABNORMAL COAGULATION CONTROLK891179EDL NORMAL COAGULATION CONTROLK890619EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT

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.

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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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