Nova Lite Anca
FDA 510(k) K961340 · Inova Diagnostics, Inc.
510(k) numberK961340
Submission
- Device name
- Nova Lite Anca
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- March 25, 1996
- Decision date
- July 10, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MOB – Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
Other 510(k)s with product code MOB
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|---|---|---|---|
| K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMMOB · Traditional | Zeus Scientific | 08/21/2026SE |
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic…MOB · Traditional | Zeus Scientific | 05/07/2025SE |
| K172582 | EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic…MOB · Traditional | Euroimmun Us, Inc. | 05/24/2018SE |
| K172461 | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA FormalinMOB · Traditional | Aesku.Diagnostics GmbH & Co. KG | 03/23/2018SE |
| K173792 | EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayMOB · Traditional | Phadia AB | 03/13/2018SE |
| K161258 | NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitMOB · Traditional | Inova Diagnostics, Inc. | 02/03/2017SE |
| K140225 | Elia PR3S Immunoassay, Elia Mpos Immunoassay, Elia GBM Immunoassay, Elia Anca/Gbm…MOB · Traditional | Phadia US, Inc. | 10/27/2014SE |
| K112545 | Quanta Flash PR3, Quanta Flash Mpo, Quanta Flash GBMMOB · Traditional | Inova Diagnostics, Inc. | 07/31/2012SE |
| K100917 | Fidis Vasculitis Assay Kit and Analyzer and Caris SystemMOB · Special | Biomedical Diagnostics (Bmd) SA | 11/03/2010SE |
| K092601 | Immulisa Anca Screen ElisaMOB · Traditional | Immco Diagnostics, Inc. | 10/07/2010SE |
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| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae KitKTL · Traditional | 12/11/2020SE |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsDHR · Traditional | 04/17/2019SE |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction DeviceNXO · Traditional | 10/16/2018SE |
| K180975 | QUANTA Flash HMGCR ReagentsLLL · Traditional | 06/25/2018SE |
| K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash…NXO · Traditional | 12/22/2017SE |
Questions and answers
When was Nova Lite Anca cleared by the FDA?
Nova Lite Anca (K961340) received a 510(k) decision of Substantially Equivalent on July 10, 1996, 107 days after the submission was received.
What is the product code of K961340?
The FDA product code is MOB – Test System, Antineutrophil Cytoplasmic Antibodies (Anca), a Class II (moderate risk) device regulated under 21 CFR 866.5660.