DeviceClearance

MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN— 510(k) K071317

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K071317 for MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN, Substantially Equivalent on 2007-08-20. Applicant: Dade Behring, Inc..

Clearance details

Applicant
Dade Behring, Inc.
Product code
Code LON
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
West Sacramento, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LON

product code LON
Malfunction
2,383
Total
2,383

Source: openFDA MAUDE database, through . 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.