EliA SymphonyS Immunoassay
FDA 510(k) K190710 · Phadia AB
510(k) numberK190710
Submission
- Device name
- EliA SymphonyS Immunoassay
- Applicant
- Phadia AB
Uppsala, SE - Received
- March 19, 2019
- Decision date
- November 29, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LLL – Extractable Antinuclear Antibody, Antigen And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
Other 510(k)s with product code LLL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253817 | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaLLL · Traditional | Immunodiagnostics Systems Limited | 08/21/2026SE |
| K253367 | EliA CTD 13 ScreenLLL · Traditional | Phadia AB | 06/25/2026SE |
| K250666 | Alegria Flash CTD ScreenLLL · Traditional | Zeus Scientific | 10/22/2025SE |
| K250408 | Alegria Flash ENA ScreenLLL · Traditional | Zeus Scientific | 09/19/2025SE |
| K213403 | Aptiva CTD Essential ReagentLLL · Traditional | Inova Diagnostics, Inc. | 09/29/2023SE |
| K180975 | QUANTA Flash HMGCR ReagentsLLL · Traditional | Inova Diagnostics, Inc. | 06/25/2018SE |
| K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 ControlsLLL · Traditional | Inova Diagnostics, Inc. | 06/01/2016SE |
| K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsLLL · Traditional | Inova Diagnostics, Inc. | 02/12/2016SE |
| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA…LLL · Traditional | Immco Diagnostics, Inc. | 03/31/2015SE |
| K141328 | Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60 ControlsLLL · Traditional | Inova Diagnostics, Inc. | 02/12/2015SE |
More from Inova Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253367 | EliA CTD 13 ScreenLLL · Traditional | 06/25/2026SE |
| K212181 | ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen…DHB · Traditional | 08/03/2022SE |
| K210902 | EliA Ro52, EliA Ro60LKJ · Traditional | 07/27/2022SE |
| K202541 | EliA RNA Pol IIINYO · Traditional | 09/13/2021SE |
| K202540 | EliA Rib-PMQA · Traditional | 09/13/2021SE |
| K202067 | EliA SmDP-SLKP · Traditional | 07/14/2021SE |
| K200279 | ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovineDHB · Traditional | 05/01/2020SE |
| K190315 | ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230…DHB · Traditional | 05/14/2019SE |
| K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG…MVM · Traditional | 03/01/2019SE |
| K183007 | EliA SmDP ImmunoassayLKP · Traditional | 12/24/2018SE |
Questions and answers
When was EliA SymphonyS Immunoassay cleared by the FDA?
EliA SymphonyS Immunoassay (K190710) received a 510(k) decision of Substantially Equivalent on November 29, 2019, 255 days after the submission was received.
What is the product code of K190710?
The FDA product code is LLL – Extractable Antinuclear Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.