NOVA Lite DAPI dsDNA Crithidia luciliae Kit
FDA 510(k) K192916 · Inova Diagnostics, Inc.
510(k) numberK192916
Submission
- Device name
- NOVA Lite DAPI dsDNA Crithidia luciliae Kit
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- October 15, 2019
- Decision date
- December 11, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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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 |
| 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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Questions and answers
When was NOVA Lite DAPI dsDNA Crithidia luciliae Kit cleared by the FDA?
NOVA Lite DAPI dsDNA Crithidia luciliae Kit (K192916) received a 510(k) decision of Substantially Equivalent on December 11, 2020, 423 days after the submission was received.
What is the product code of K192916?
The FDA product code is KTL – Anti-Dna Indirect Immunofluorescent Solid Phase, a Class II (moderate risk) device regulated under 21 CFR 866.5100.