Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
- 510(k)K123593Substantially equivalent (SESE) · 2013-04-17clearance family
Predicate lineage
K123593
Cited as predicate by: K213403
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
None in the loaded window.
Similar devices
- Anti-Sm ELISA (IgG) EUROIMMUN Medizinische Labordiagnostika AG
- Autoimmune EIA BIO-RAD LABORATORIES, INC.
- Autostat II Anti-Sm HYCOR BIOMEDICAL LLC
- DIASTAT anti-Sm/RNP Svar Life Science AB
- DIASTST anti-Sm Svar Life Science AB
- EUROLINE ENA Profile 9 Ag (IgG) EUROIMMUN Medizinische Labordiagnostika AG
- EUROLINE ENA Profile 9 Ag (IgG) EUROIMMUN Medizinische Labordiagnostika AG
- EUROLINE ENA ProfilePlus 4 (IgG) EUROIMMUN Medizinische Labordiagnostika AG
- EUROLINE ENA ProfilePlus 4 (IgG) EUROIMMUN Medizinische Labordiagnostika AG
- EliA SmDP Well Phadia AB
- EliA SmDP-S Well Phadia AB
- Liquichek BIO-RAD LABORATORIES, INC.
Select up to two to place side-by-side with this device.