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FDA 510(k)

EDL NORMAL COAGULATION CONTROL

K-Number: K891179 · 1989-04-10

ApplicantElite Diagnostic , Ltd.
Decision Date1989-04-10
Product CodeGIZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EDL NORMAL COAGULATION CONTROL 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 1989-04-10 under 510(k) number K891179. The device is classified under product code GIZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDL NORMAL COAGULATION CONTROL?

EDL NORMAL COAGULATION CONTROL is a medical device that received FDA 510(k) clearance on 1989-04-10. The listed applicant is Elite Diagnostic , Ltd.. The 510(k) number is K891179.

When did EDL NORMAL COAGULATION CONTROL receive FDA 510(k) clearance?

EDL NORMAL COAGULATION CONTROL received FDA 510(k) clearance on 1989-04-10, under 510(k) number K891179.

Who is the listed applicant for EDL NORMAL COAGULATION CONTROL?

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 NORMAL COAGULATION CONTROL?

The FDA product code for EDL NORMAL COAGULATION CONTROL is GIZ.

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 TIMEK891370EDL ONE-STAGE PROTHROMBIN TIME REAGENTK891175EDL ABNORMAL COAGULATION CONTROLK890619EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT

Related Devices (Code: GIZ)

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.

K060968STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOWWortham Laboratories, Inc.K042941DADE BEHRING HEPARIN CALIBRATOR AND CONTROLSDade Behring, Inc.K023309CONTROL PLASMA NDade Behring, Inc.K013708REFERENCE CHECK, CATALOG NUMBER-RCN-10Precision BiologicK003328ACCUCLOT CONTROL I, MODEL A4089Sigma Diagnostics, Inc.K001256CONTROL PLASMA NDade Behring, Inc.

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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