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FDA 510(k)

ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN

K-Number: K932850 · 1993-09-24

ApplicantHelix Diagnostics, Inc.
Decision Date1993-09-24
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN 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 1993-09-24 under 510(k) number K932850. 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 IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN?

ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN is a medical device that received FDA 510(k) clearance on 1993-09-24. The listed applicant is Helix Diagnostics, Inc.. The 510(k) number is K932850.

When did ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN receive FDA 510(k) clearance?

ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN received FDA 510(k) clearance on 1993-09-24, under 510(k) number K932850.

Who is the listed applicant for ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN?

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 IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN?

The FDA product code for ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN 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 TESTK000489ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TESTK980337DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEMK960091ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KITK954700ENZYME IMMUNOASSAY LUPUS SCREEN TEST KITK954723ENZYME IMMUNOASSAY ANA 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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