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FDA 510(k)

REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT

K-Number: K001398 · 2001-03-30

ApplicantCorgenix, Inc.
Decision Date2001-03-30
Product CodeDHC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Corgenix, Inc.. It received FDA 510(k) clearance on 2001-03-30 under 510(k) number K001398. The device is classified under product code DHC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT?

REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT is a medical device that received FDA 510(k) clearance on 2001-03-30. The listed applicant is Corgenix, Inc.. The 510(k) number is K001398.

When did REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT receive FDA 510(k) clearance?

REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT received FDA 510(k) clearance on 2001-03-30, under 510(k) number K001398.

Who is the listed applicant for REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT?

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

What is the FDA product code for REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT?

The FDA product code for REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT is DHC.

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Other records listing Corgenix, Inc. 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.

K072032IGG ANTI-ATHEROX TEST KITK062025ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136K042680RHIGENE HEP-ANA TEST SYSTEMK032139REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826K034013REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001K032868REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139

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Related Devices (Code: DHC)

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.

K001352REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KITCorgenix, Inc.K930247HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USEThe Binding Site, Ltd.K930421ELIAS DSDNA ABSElias U.S.A., Inc.K914801IMMUNOWELL DSDNA ANTIBODY TESTGeneral Biometrics, Inc.K885048ACCESS R-CLONE ANA PROFILE ASSAYLipogen, Inc.K872910IMMUNO/SLEImmunostics Co., 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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