SS-DNA EIA Diagnostic Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K870452 ↗

FDA Product Code

LJM

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Rnp Eia Diagnostic Kit

  Class II

  FDA 510(k) K870457 Active Cleared 17 Mar 1987

• Histones Eia Diagnostic Kit

  Class II

  FDA 510(k) K870458 Active Cleared 17 Mar 1987

• Dnp Eia Diagnostic Kit

  Class II

  FDA 510(k) K870456 Active Cleared 17 Mar 1987

• DS-DNA EIA Diagnostic Kit

  Class II

  FDA 510(k) K870453 Active Cleared 24 Mar 1987

• Ana-Enzyme Immunoassay (Ana-Eia) Diagnostic Kit

  Class II

  FDA 510(k) K862969 Active Cleared 24 Oct 1986

• Sm Eia Diagnostic Kit

  Class II

  FDA 510(k) K870455 Active Cleared 17 Mar 1987

• What is the SS-DNA EIA Diagnostic Kit used for?

  The SS-DNA EIA Diagnostic Kit is an antinuclear antibody enzyme-labeled diagnostic kit used for the detection of antibodies to single-stranded DNA in immunology testing, as specified in its device description and classification under regulation number 866.5100.

• How was the SS-DNA EIA Diagnostic Kit cleared for market in the United States?

  The device received FDA 510(k) clearance (K870452) on March 17, 1987, as substantially equivalent to a predicate device, based on a traditional 510(k) submission reviewed by the Immunology advisory committee.

• Who manufactures the SS-DNA EIA Diagnostic Kit and where is it produced?

  The SS-DNA EIA Diagnostic Kit is manufactured by Biohytech International, Inc., located at 10 W. 35th St., Chicago, Illinois 60616, United States, as indicated in the device’s authorization and facility details.

• What regulatory classification and product code apply to the SS-DNA EIA Diagnostic Kit?

  The device is classified as a Class II medical device under regulation number 866.5100, with product code LJM, and falls under the immunology medical specialty as defined in its FDA 510(k) documentation.

• Is the SS-DNA EIA Diagnostic Kit intended for use in a specific medical specialty?

  Yes, the device is intended for use in immunology testing, as explicitly stated in its description and confirmed by the medical_specialty_description field and advisory committee designation (IM) in the authorization data.