Orgentec ANTI-PR3 (C-Anca) Elisa
FDA 510(k) K974702 · American Laboratory Products Co., Ltd.
510(k) numberK974702
Submission
- Device name
- Orgentec ANTI-PR3 (C-Anca) Elisa
- Applicant
- American Laboratory Products Co., Ltd.
Windham, NH, US - Received
- December 8, 1997
- Decision date
- February 17, 1998
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Immco Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K012576 | CIC-C1Q EiaDAK · Traditional | 01/29/2002SE |
| K011415 | Alpco Milenia Anti-Tg EiaJZO · Traditional | 05/30/2001SE |
| K011201 | Alpco Milenia Anti-Tpo ElisaJZO · Traditional | 05/24/2001SE |
| K974701 | Orgentec Anti-Mpo (P-Anca) ElisaMOB · Traditional | 02/17/1998SE |
| K972190 | Thyroglobulin Assay SystemJZO · Traditional | 07/14/1997SE |
| K970932 | Orgentec Micro-Albumin Eia AssayJIR · Traditional | 04/08/1997SE |
| K962062 | Orgentec Anti-Sm ElisaLJM · Traditional | 11/18/1996SE |
| K962057 | Orgentec Anti-Rnp/Sm ElisaLJM · Traditional | 11/18/1996SE |
| K962055 | Orgentec Anti-Scl 70 ElisaLJM · Traditional | 11/15/1996SE |
| K962054 | Orgentec Anti-Ss-A(Ro) ElisaLJM · Traditional | 11/15/1996SE |
Questions and answers
When was Orgentec ANTI-PR3 (C-Anca) Elisa cleared by the FDA?
Orgentec ANTI-PR3 (C-Anca) Elisa (K974702) received a 510(k) decision of Substantially Equivalent on February 17, 1998, 71 days after the submission was received.
What is the product code of K974702?
The FDA product code is MOB – Test System, Antineutrophil Cytoplasmic Antibodies (Anca), a Class II (moderate risk) device regulated under 21 CFR 866.5660.