DIASTAT ANTI-PR3 (C-ANCA) KIT
FDA 510(k) clearance K942813 · decided 1995-03-06
Clearance details
- K-number
- K942813
- Device name
- DIASTAT ANTI-PR3 (C-ANCA) KIT
- Applicant
- Shield Diagnostics, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1994-06-14
- Decision date
- 1995-03-06
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- MOB
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Dundee, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Shield Diagnostics
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API,
or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) (K243776) | Zeus Scientific | 2025-05-07 |
| EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern (K172582) | Euroimmun Us, Inc. | 2018-05-24 |
| AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin (K172461) | Aesku.Diagnostics GmbH & Co. KG | 2018-03-23 |
| EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay (K173792) | Phadia AB | 2018-03-13 |
| NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit (K161258) | Inova Diagnostics, Inc. | 2017-02-03 |
| ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO (K140225) | Phadia US, Inc. | 2014-10-27 |
| QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM (K112545) | Inova Diagnostics, Inc. | 2012-07-31 |
| FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM (K100917) | Biomedical Diagnostics (Bmd) SA | 2010-11-03 |
| IMMULISA PR3 ANTIBODY ELISA (K092600) | Immco Diagnostics, Inc. | 2010-10-07 |
| IMMULISA ANCA SCREEN ELISA (K092601) | Immco Diagnostics, Inc. | 2010-10-07 |
| IMMULISA MPO ANTIBODY ELISA (K092599) | Immco Diagnostics, Inc. | 2010-10-07 |
| AESKU PR3 (K091859) | Aesku Diagnostics | 2010-06-03 |
Recalls involving this device
No recalls on record reference this clearance.