MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025— 510(k) K092919

Substantially Equivalent

Siemens Healthcare Diagnostics

FDA 510(k) clearance K092919 for MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025, Substantially Equivalent on 2009-10-23. Applicant: Siemens Healthcare Diagnostics.

Clearance details

Applicant: Siemens Healthcare Diagnostics
Product code: Code LON
Advisory panel: Microbiology
Date received: 2009-09-23
Decision date: 2009-10-23
Decision: Substantially Equivalent
Clearance type: Special
Location: West Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LON

product code LON

Malfunction: 2,383
Total: 2,383

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.