ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
FDA 510(k) K231616 · Zeus Scientific
510(k) numberK231616
Submission
- Device name
- ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
- Applicant
- Zeus Scientific
Branchburg, NJ, US - Received
- June 2, 2023
- Decision date
- August 31, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KTL – Anti-Dna Indirect Immunofluorescent Solid Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
Other 510(k)s with product code KTL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K864275 | Anti-Ndna Antibody Test KitKTL · Traditional | Cappel Diagnostics, Inc. | 12/15/1986SE |
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| K191398 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | 07/29/2019SE |
| K191240 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | 07/29/2019SE |
| K190907 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | 07/29/2019SE |
Questions and answers
When was ZEUS IFA(TM) nDNA Test System, ZEUS dIFine cleared by the FDA?
ZEUS IFA(TM) nDNA Test System, ZEUS dIFine (K231616) received a 510(k) decision of Substantially Equivalent on August 31, 2023, 90 days after the submission was received.
What is the product code of K231616?
The FDA product code is KTL – Anti-Dna Indirect Immunofluorescent Solid Phase, a Class II (moderate risk) device regulated under 21 CFR 866.5100.