MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)— 510(k) K033482

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K033482 for MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML), Substantially Equivalent on 2003-11-26. Applicant: Dade Behring, Inc..

Clearance details

Applicant: Dade Behring, Inc.
Product code: Code LON
Advisory panel: Microbiology
Date received: 2003-11-04
Decision date: 2003-11-26
Decision: Substantially Equivalent
Clearance type: Special
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.