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FDA 510(k)

ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST

K-Number: K001900 · 2000-09-11

ApplicantHelix Diagnostics, Inc.
Decision Date2000-09-11
Product CodeLRM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST 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 2000-09-11 under 510(k) number K001900. The device is classified under product code LRM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST?

ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 2000-09-11. The listed applicant is Helix Diagnostics, Inc.. The 510(k) number is K001900.

When did ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST receive FDA 510(k) clearance?

ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST received FDA 510(k) clearance on 2000-09-11, under 510(k) number K001900.

Who is the listed applicant for ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST?

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 ANTI-SSDNA ANTIBODY TEST?

The FDA product code for ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST is LRM.

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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.

K000489ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TESTK980337DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEMK960091ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KITK954723ENZYME IMMUNOASSAY ANA SCREENING TEST KITK954700ENZYME IMMUNOASSAY LUPUS SCREEN TEST KITK952253ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT

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Related Devices (Code: LRM)

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.

K101319IMMULISA DSDNA ANTIBODY ELISAImmco Diagnostics, Inc.K083381EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)Euroimmun Us, Inc.K062183FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KITThe Binding Site, Ltd.K040811VARELISA SSDNA ANTIBODIES, MODEL 14896Pharmacia Deutschland GmbHK000477MDI DS-DNA TESTMicro Detect, Inc.K994424DIAMEDIX IS-ANTI-DSDNA TEST SYSTEMDiamedix Corp.

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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