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FDA 510(k)

LUCOR CONFIRMATORY REAGENT

K-Number: K922156 · 1993-04-06

ApplicantGradipore , Ltd.
Decision Date1993-04-06
Product CodeGIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LUCOR CONFIRMATORY REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Gradipore , Ltd.. It received FDA 510(k) clearance on 1993-04-06 under 510(k) number K922156. The device is classified under product code GIR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUCOR CONFIRMATORY REAGENT?

LUCOR CONFIRMATORY REAGENT is a medical device that received FDA 510(k) clearance on 1993-04-06. The listed applicant is Gradipore , Ltd.. The 510(k) number is K922156.

When did LUCOR CONFIRMATORY REAGENT receive FDA 510(k) clearance?

LUCOR CONFIRMATORY REAGENT received FDA 510(k) clearance on 1993-04-06, under 510(k) number K922156.

Who is the listed applicant for LUCOR CONFIRMATORY REAGENT?

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

What is the FDA product code for LUCOR CONFIRMATORY REAGENT?

The FDA product code for LUCOR CONFIRMATORY REAGENT is GIR.

Related Clinical Trials

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Other records listing Gradipore , 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.

K993332GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05K992456GRADILEIDEN V TESTK903037LUPO-TEST REAGENT

Related Devices (Code: GIR)

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.

K110031HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRMInstrumentation Laboratory COK083878LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LAR2 Diagnostics, Inc.K061805STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRMDiagnostica Stago, Inc.K000528ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119Sigma Diagnostics, Inc.K000527ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094Sigma Diagnostics, Inc.K990580CRYOCHECK LA SURE, MODEL SUR25-10Precision Biologic

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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