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FDA 510(k)

ATHENA MULTI-LYTE ANA-II TEST SYSTEM

K-Number: K042416 · 2004-10-08

ApplicantZeus Scientific, Inc.
Decision Date2004-10-08
Product CodeLKJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ATHENA MULTI-LYTE ANA-II TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific, Inc.. It received FDA 510(k) clearance on 2004-10-08 under 510(k) number K042416. 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 ATHENA MULTI-LYTE ANA-II TEST SYSTEM?

ATHENA MULTI-LYTE ANA-II TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2004-10-08. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K042416.

When did ATHENA MULTI-LYTE ANA-II TEST SYSTEM receive FDA 510(k) clearance?

ATHENA MULTI-LYTE ANA-II TEST SYSTEM received FDA 510(k) clearance on 2004-10-08, under 510(k) number K042416.

Who is the listed applicant for ATHENA MULTI-LYTE ANA-II TEST SYSTEM?

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

What is the FDA product code for ATHENA MULTI-LYTE ANA-II TEST SYSTEM?

The FDA product code for ATHENA MULTI-LYTE ANA-II TEST SYSTEM is LKJ.

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Other records listing Zeus Scientific, Inc. as applicant

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K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineK190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test SystemK191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test SystemK191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SystemK113397ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEMK102425ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM

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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.K034013REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001Corgenix, 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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