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FDA 510(k)

ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST

K-Number: K000489 · 2000-04-05

ApplicantHelix Diagnostics, Inc.
Decision Date2000-04-05
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ENZYME IMMUNOASSAY ANTI-CENTROMERE 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 2000-04-05 under 510(k) number K000489. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST?

ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 2000-04-05. The listed applicant is Helix Diagnostics, Inc.. The 510(k) number is K000489.

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

ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST received FDA 510(k) clearance on 2000-04-05, under 510(k) number K000489.

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

The FDA product code for ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST is LLL.

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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 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: LLL)

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.

K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems LimitedK253367EliA CTD 13 ScreenPhadia ABK250666Alegria Flash CTD ScreenZeus ScientificK250408Alegria Flash ENA ScreenZeus ScientificK213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.K190710EliA SymphonyS ImmunoassayPhadia AB

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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