Autostat II Anti-Ss-A/Ro Elisa
FDA 510(k) K990627 · Cogent Diagnotics , Ltd.
510(k) numberK990627
Submission
- Device name
- Autostat II Anti-Ss-A/Ro Elisa
- Applicant
- Cogent Diagnotics , Ltd.
Midlothian, Scotland, GB - Received
- February 25, 1999
- Decision date
- April 28, 1999
- 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 |
|---|---|---|
| K003057 | Autostat II ENA-4 Profile ElisaLLL · Traditional | 10/13/2000SE |
| K003054 | Autostat II ENA-6 Profile ElisaLLL · Traditional | 10/13/2000SE |
| K002215 | Autostat II Anti-Myeloperoxidase (Mpo) ElisaMOB · Traditional | 09/28/2000SE |
| K993557 | Autostat II Rheumatoid Factor Iga ElisaDHR · Traditional | 03/03/2000SE |
| K994338 | Autostat II Rheumatoid Factor Igm ElisaDHR · Traditional | 02/03/2000SE |
| K993085 | Autostat II Anti-Cardiolipin Screen ElisaMID · Traditional | 02/01/2000SE |
| K993304 | Autostat II Rheumatoid Factor Igg ElisaDHR · Traditional | 12/06/1999SE |
| K992449 | Autostat II Anti-Cardiolipin Igm ElisaMID · Traditional | 11/24/1999SE |
| K993087 | Autostat II Anti-Gliadin Igg ElisaMST · Traditional | 11/12/1999SE |
| K993086 | Autostat II Anti-Gliadin Iga ElisaMST · Traditional | 11/12/1999SE |
Questions and answers
When was Autostat II Anti-Ss-A/Ro Elisa cleared by the FDA?
Autostat II Anti-Ss-A/Ro Elisa (K990627) received a 510(k) decision of Substantially Equivalent on April 28, 1999, 62 days after the submission was received.
What is the product code of K990627?
The FDA product code is LLL – Extractable Antinuclear Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.