Immunodot Autoimmunity Screening Panel 3
FDA 510(k) K902938 · General Biometrics, Inc.
510(k) numberK902938
Submission
- Device name
- Immunodot Autoimmunity Screening Panel 3
- Applicant
- General Biometrics, Inc.
San Diego, CA, US - Received
- July 3, 1990
- Decision date
- August 9, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| 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 |
|---|---|---|
| K924843 | Immunodot(R) Ena/Dna Autoimmunity Screening PanelLLL · Traditional | 12/01/1992SE |
| K920401 | Immunowell Cardiolipin Antibody (Igm) TestMID · Traditional | 08/20/1992SE |
| K920400 | Immunowell Cardiolipin Antibody (Igg) TestMID · Traditional | 08/20/1992SE |
| K911627 | Immunodot Borrelia (Lyme) TestLSR · Traditional | 04/08/1992SE |
| K911599 | Immunowell Lyme (P39 Recombinant) TestLSR · Traditional | 12/30/1991SE |
| K911590 | Immunowell Borrelia (Lyme)TestLSR · Traditional | 12/20/1991SE |
| K914801 | Immunowell Dsdna Antibody TestDHC · Traditional | 12/09/1991SE |
| K911851 | Immunowell SM Antibody TestLKP · Traditional | 05/07/1991SE |
| K911850 | Immunwell Sjogren`S Syndrome B (la) Antibody TestLKO · Traditional | 05/07/1991SE |
| K911849 | Immunowell Sjogrens Syndrome a (Ro)Antibody TestLKO · Traditional | 05/07/1991SE |
Questions and answers
When was Immunodot Autoimmunity Screening Panel 3 cleared by the FDA?
Immunodot Autoimmunity Screening Panel 3 (K902938) received a 510(k) decision of Substantially Equivalent on August 9, 1990, 37 days after the submission was received.
What is the product code of K902938?
The FDA product code is LLL – Extractable Antinuclear Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.