SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS— 510(k) K052346

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K052346 for SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS, Substantially Equivalent on 2005-10-26. Applicant: Dade Behring, Inc..

Clearance details

Applicant: Dade Behring, Inc.
Product code: Code LON
Advisory panel: Microbiology
Date received: 2005-08-29
Decision date: 2005-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

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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.