Aeskulisa Ena 6 S
FDA 510(k) K041753 · Aesku Diagnostics
510(k) numberK041753
Submission
- Device name
- Aeskulisa Ena 6 S
- Applicant
- Aesku Diagnostics
Miami, FL, US - Received
- June 29, 2004
- Decision date
- July 14, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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| K250666 | Alegria Flash CTD ScreenLLL · Traditional | Zeus Scientific | 10/22/2025SE |
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| 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 |
|---|---|---|
| K172461 | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA FormalinMOB · Traditional | 03/23/2018SE |
| K172348 | AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit…LSW · Traditional | 02/16/2018SE |
| K132082 | Aeskulisa Dgp-A, Aeskulisa Dgp-G,Aeskulisa Dgp-CheckMST · Traditional | 12/05/2013SE |
| K120889 | Aeskuslides Ana HEP-2DHN · Traditional | 10/15/2012SE |
| K091859 | Aesku PR3MOB · Traditional | 06/03/2010SE |
| K091860 | Aeskulisa Mpo, Model 30-7303USMOB · Traditional | 02/23/2010SE |
| K081251 | Modification to Aeskulisa DS DNA GLSW · Special | 05/13/2008SE |
| K081104 | Aeskulisa Ana HEP-2, Ref 30-7115USLKJ · Traditional | 05/02/2008SE |
| K052439 | Aeskulisa Glia a and Aeskulisa Glia GMST · Traditional | 02/07/2006SE |
| K041628 | Aeskulisa DS DNA GLSW · Traditional | 10/14/2004SE |
Questions and answers
When was Aeskulisa Ena 6 S cleared by the FDA?
Aeskulisa Ena 6 S (K041753) received a 510(k) decision of Substantially Equivalent on July 14, 2004, 15 days after the submission was received.
What is the product code of K041753?
The FDA product code is LLL – Extractable Antinuclear Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.