Antinuclear Antibody Immunological Sys
FDA 510(k) K834140 · Intl. Diagnostic Technology
510(k) numberK834140
Submission
- Device name
- Antinuclear Antibody Immunological Sys
- Applicant
- Intl. Diagnostic Technology
Mchenry, IL, US - Received
- November 30, 1983
- Decision date
- January 20, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KTL – Anti-Dna Indirect Immunofluorescent Solid Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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| K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFineKTL · Traditional | Zeus Scientific | 08/31/2023SE |
| K203599 | Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test SystemKTL · Traditional | Immuno Concepts, N.A. , Ltd. | 05/26/2023SE |
| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae KitKTL · Traditional | Inova Diagnostics, Inc. | 12/11/2020SE |
| K172252 | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternKTL · Traditional | Euroimmun Us, Inc. | 04/20/2018SE |
| K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternKTL · Traditional | Euroimmun Us, Inc. | 04/20/2018SE |
| K011068 | Rhigene Ndna Test System for Imagetiter, Model CL100LKTL · Traditional | Rhigene, Inc. | 04/11/2002SE |
| K013432 | Igg Anti-Ndna Fluorescent Test System; Model # 3040GKTL · Traditional | Immuno Concepts, Inc. | 11/29/2001SE |
| K990916 | Indirect Fluorescence Assay for Anti-Native DNA Igg AntibodyKTL · Traditional | Stellar Bio Systems, Inc. | 04/21/1999SE |
| K930987 | Crithidia Lucilliae DS DNA Kit (Diagnostic Use)KTL · Traditional | The Binding Site, Ltd. | 08/10/1993SE |
| K905386 | Distat Anti-Dsdna KitKTL · Traditional | Shield Diagnostics, Ltd. | 12/13/1990SE |
More from Shield Diagnostics, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K850591 | Fiax Toxo-M Antibodies Test KitGLZ · Traditional | 04/30/1985SE |
| K843570 | Fiax Haptoglobin Test KitDAB · Traditional | 10/05/1984SE |
| K843621 | Fiax 420 DilutorJQW · Traditional | 09/28/1984SE |
| K843356 | Fiax 100 FluorometerJZT · Traditional | 09/17/1984SE |
| K842749 | Fiax Total Ige Test KitDGP · Traditional | 08/28/1984SE |
| K842071 | Fiax Transferrin Test KitDDI · Traditional | 07/11/1984SE |
| K841174 | Rubella Antibody FluoroimmunoassayGOL · Traditional | 06/07/1984SE |
| K840867 | ALPHA-1-ANTITRYPSIN, Fitc, AntigenDEI · Traditional | 05/11/1984SE |
| K833984 | Antinuclear Antibody ImmunologicalKTL · Traditional | 01/04/1984SE |
| K832821 | Fiax Igg TestDFI · Traditional | 10/14/1983SE |
Questions and answers
When was Antinuclear Antibody Immunological Sys cleared by the FDA?
Antinuclear Antibody Immunological Sys (K834140) received a 510(k) decision of Substantially Equivalent on January 20, 1984, 51 days after the submission was received.
What is the product code of K834140?
The FDA product code is KTL – Anti-Dna Indirect Immunofluorescent Solid Phase, a Class II (moderate risk) device regulated under 21 CFR 866.5100.