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FDA 510(k)

EDL ABNORMAL COAGULATION CONTROL

K-Number: K891175 · 1989-04-10

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

Device Summary

EDL ABNORMAL 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 K891175. The device is classified under product code GGL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDL ABNORMAL COAGULATION CONTROL?

EDL ABNORMAL 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 K891175.

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

EDL ABNORMAL COAGULATION CONTROL received FDA 510(k) clearance on 1989-04-10, under 510(k) number K891175.

Who is the listed applicant for EDL ABNORMAL 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 ABNORMAL COAGULATION CONTROL?

The FDA product code for EDL ABNORMAL COAGULATION CONTROL is GGL.

Related Clinical Trials

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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 REAGENTK891179EDL NORMAL COAGULATION CONTROLK890619EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT

Related Devices (Code: GGL)

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.

K083926CD4 COUNTStreckK051633CD-CHEX PLUS BCStreckK993126CD-CHEX CD 34Streck Laboratories, Inc.K960894CD-CHEX + RBCStreck Laboratories, Inc.K931825CD-CHEX CD4 LOWStreck Laboratories, Inc.K920997CD-CHEXStreck Laboratories, Inc.

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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