Orgentec Enascreen Elisa Assay
FDA 510(k) K955134 · Orgentec
510(k) numberK955134
Submission
- Device name
- Orgentec Enascreen Elisa Assay
- Applicant
- Orgentec
Windham, NH, US - Received
- November 9, 1995
- Decision date
- March 20, 1996
- 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
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 |
| 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 |
|---|---|---|
| K954831 | Orgentec Anti-Rnp/Sm Pin Immuno AssayLKO · Traditional | 05/08/1996SE |
| K954830 | Orgentec Anti-Sm(Smith) Pin Immuno AssayLKP · Traditional | 05/08/1996SE |
| K954832 | Orgentec Anti-Ss-B(La) Pin Immuno AssayLJM · Traditional | 04/18/1996SE |
| K954829 | Orgentec ANTI-JO-1 Pin Immuno AssayLJM · Traditional | 04/18/1996SE |
| K954815 | Orgentec Anti-Ss-A(Ro) Pin Immuno AssayLJM · Traditional | 04/18/1996SE |
| K954814 | Orgentec Anti-Scl 70 Pin Immuno AssayLJM · Traditional | 04/18/1996SE |
| K960274 | Orgentec Micro-Albumin Pin Eia AssayJIR · Traditional | 03/29/1996SE |
| K955133 | Orgentec Enascreen Pin Immuno AssayLLL · Traditional | 03/20/1996SE |
| K953671 | Orgen Tec Anti-Dsdna Elisa AssayLRM · Traditional | 11/09/1995SE |
Questions and answers
When was Orgentec Enascreen Elisa Assay cleared by the FDA?
Orgentec Enascreen Elisa Assay (K955134) received a 510(k) decision of Substantially Equivalent on March 20, 1996, 132 days after the submission was received.
What is the product code of K955134?
The FDA product code is LLL – Extractable Antinuclear Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.