EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern
FDA 510(k) K172252 · Euroimmun Us, Inc.
510(k) numberK172252
Submission
- Device name
- EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern
- Applicant
- Euroimmun Us, Inc.
Mountain Lakes, NJ, US - Received
- July 26, 2017
- Decision date
- April 20, 2018
- 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 |
|---|---|---|---|
| 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 |
| 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 |
More from Cappel Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K193115 | EUROIMMUN Anti-BP230-CF ELISA (IgG)OEG · Traditional | 09/17/2020SE |
| K183313 | EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue…MVM · Traditional | 02/28/2019SE |
| K172582 | EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic…MOB · Traditional | 05/24/2018SE |
| K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternKTL · Traditional | 04/20/2018SE |
| K172722 | Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)LSR · Traditional | 12/10/2017SE |
| K161513 | Anti-Borrelia burgdorferi US Westernblot (IgG)LSR · Traditional | 08/25/2016SE |
| K153308 | EUROIMMUN Anti-West Nile Virus ELISA (IgM)NOP · Traditional | 08/12/2016SE |
| K153303 | EUROIMMUN Anti-West Nile Virus ELISA (IgG)NOP · Traditional | 08/10/2016SE |
| K142038 | EUROIMMUN LYME ELISA(IgG/IgM)LSR · Traditional | 05/04/2015SE |
| K141827 | Euroimmun Ifa 40: HEP-20-10; Europattern Microscope and SoftwareDHN · Traditional | 04/17/2015SE |
Questions and answers
When was EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern cleared by the FDA?
EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern (K172252) received a 510(k) decision of Substantially Equivalent on April 20, 2018, 268 days after the submission was received.
What is the product code of K172252?
The FDA product code is KTL – Anti-Dna Indirect Immunofluorescent Solid Phase, a Class II (moderate risk) device regulated under 21 CFR 866.5100.