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FDA 510(k)

ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT

K-Number: K954700 · 1995-12-15

ApplicantHelix Diagnostics, Inc.
Decision Date1995-12-15
Product CodeLKJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Helix Diagnostics, Inc.. It received FDA 510(k) clearance on 1995-12-15 under 510(k) number K954700. 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 ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT?

ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT is a medical device that received FDA 510(k) clearance on 1995-12-15. The listed applicant is Helix Diagnostics, Inc.. The 510(k) number is K954700.

When did ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT receive FDA 510(k) clearance?

ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT received FDA 510(k) clearance on 1995-12-15, under 510(k) number K954700.

Who is the listed applicant for ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT?

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

What is the FDA product code for ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT?

The FDA product code for ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT is LKJ.

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Other records listing Helix Diagnostics, 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.

K001900ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TESTK000489ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TESTK980337DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEMK960091ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KITK954723ENZYME IMMUNOASSAY ANA SCREENING TEST KITK952253ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT

View all 15 devices →

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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