Relisa Ena Single Well Screen Antibody Test System
FDA 510(k) K963275 · Immuno Concepts, Inc.
510(k) numberK963275
Submission
- Device name
- Relisa Ena Single Well Screen Antibody Test System
- Applicant
- Immuno Concepts, Inc.
Dallas, TX, US - Received
- August 20, 1996
- Decision date
- September 13, 1996
- 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
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|---|---|---|---|
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| 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 |
| K190710 | EliA SymphonyS ImmunoassayLLL · Traditional | Phadia AB | 11/29/2019SE |
| 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 |
More from Immco Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K013432 | Igg Anti-Ndna Fluorescent Test System; Model # 3040GKTL · Traditional | 11/29/2001SE |
| K013285 | Relisa Mpo-Anca Test System for Antibodies to Myeloperoxidase, Model # 7096-15MOB · Traditional | 11/14/2001SE |
| K013283 | Relisa PR3-ANCA Test System for Antibodies to Proteinase 3, Model # 7096-16MOB · Traditional | 11/14/2001SE |
| K992041 | Relisa Ana Screening Test System, Model 7096-11LJM · Traditional | 07/23/1999SE |
| K983924 | HEP-2000 Colorzyme Ana-Ro Test System, Model 4200-RODHN · Traditional | 12/18/1998SE |
| K972145 | HEP-2000 Fluorescent Ana-Ro Test SystemDHN · Traditional | 02/24/1998SE |
| K974478 | Immuno Concepts Anca Test SystemsMOB · Traditional | 02/09/1998SE |
| K974463 | Immuno Concepts Anca Test SystemMOB · Traditional | 02/09/1998SE |
| K955605 | Relisa JO-1 Antibody Test SystemLLL · Traditional | 04/19/1996SE |
| K955604 | Relisa Sm/Rnp Antibody Test SystemLLL · Traditional | 04/19/1996SE |
Questions and answers
When was Relisa Ena Single Well Screen Antibody Test System cleared by the FDA?
Relisa Ena Single Well Screen Antibody Test System (K963275) received a 510(k) decision of Substantially Equivalent on September 13, 1996, 24 days after the submission was received.
What is the product code of K963275?
The FDA product code is LLL – Extractable Antinuclear Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.