JO-1 Eia Test Kit
FDA 510(k) K935417 · David A. Fuccillo, Ph.D.
510(k) numberK935417
Submission
- Device name
- JO-1 Eia Test Kit
- Applicant
- David A. Fuccillo, Ph.D.
Washington, D.C., DC, US - Received
- November 9, 1993
- Decision date
- May 5, 1994
- 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 |
| 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 |
|---|---|---|
| K935413 | Ena Eia Test KitLLL · Traditional | 06/02/1994SE |
| K935419 | La Eia Test KitLLL · Traditional | 05/05/1994SE |
| K935418 | SCL-70 Eia Test KitLLL · Traditional | 05/05/1994SE |
| K940251 | Mitochondria Eia Test KitDBM · Traditional | 05/03/1994SE |
| K940253 | Histone Eia Test KitLJM · Traditional | 05/02/1994SE |
| K935416 | Ro Eia Test KitLJM · Traditional | 05/02/1994SE |
| K935415 | RNP Eia Test KitLJM · Traditional | 05/02/1994SE |
| K935414 | SM Eia Test KitLJM · Traditional | 05/02/1994SE |
Questions and answers
When was JO-1 Eia Test Kit cleared by the FDA?
JO-1 Eia Test Kit (K935417) received a 510(k) decision of Substantially Equivalent on May 5, 1994, 177 days after the submission was received.
What is the product code of K935417?
The FDA product code is LLL – Extractable Antinuclear Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.