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FDA 510(k)

REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001

K-Number: K034013 · 2004-01-08

ApplicantCorgenix, Inc.
Decision Date2004-01-08
Product CodeLKJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 is the device name listed in this FDA 510(k) record. The listed applicant is Corgenix, Inc.. It received FDA 510(k) clearance on 2004-01-08 under 510(k) number K034013. The device is classified under product code LKJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001?

REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 is a medical device that received FDA 510(k) clearance on 2004-01-08. The listed applicant is Corgenix, Inc.. The 510(k) number is K034013.

When did REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 receive FDA 510(k) clearance?

REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 received FDA 510(k) clearance on 2004-01-08, under 510(k) number K034013.

Who is the listed applicant for REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001?

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 DSDNA QUANTITATIVE TEST KIT, MODEL 022-001?

The FDA product code for REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 is LKJ.

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Related Devices (Code: LKJ)

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.

K210902EliA Ro52, EliA Ro60Phadia ABK113610ANA-SCREEN WITH MDSSBio-Rad LaboratoriesK082759ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAYPhadia US, Inc.K081104AESKULISA ANA HEP-2, REF 30-7115USAesku DiagnosticsK041658BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200Bio-Rad Laboratories, Inc.K042416ATHENA MULTI-LYTE ANA-II TEST SYSTEMZeus Scientific, 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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