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
Predicate lineage
K073178
Cited as predicate by: K151960
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
- ABX Minotrol 16 HORIBA ABX SAS
- ABX Minotrol 16 HORIBA ABX SAS
- ABX Minotrol 16 HORIBA ABX SAS
- ADVIA® 120/2120/2120i TESTpoint CSF Control Kit Siemens Healthcare Diagnostics Inc.
- ADVIA® 120/2120/2120i TESTpoint Retic High Control Siemens Healthcare Diagnostics Inc.
- ADVIA® 120/2120/2120i TESTpoint Retic Low Control Siemens Healthcare Diagnostics Inc.
- ADVIA® 360 Control Siemens Healthcare Diagnostics Inc.
- ADVIA® 560 Control Siemens Healthcare Diagnostics Inc.
- AQUIOS IMMUNO-TROL Cells BECKMAN COULTER IRELAND INC.
- AQUIOS IMMUNO-TROL Low Cells BECKMAN COULTER IRELAND INC.
- Advanced Instruments GloCyte RBC & TNC Verification & Linearity Kit Advanced Instruments, LLC
- Advanced Instruments GloCyte® Controls Kit Advanced Instruments, LLC
Select up to two to place side-by-side with this device.