MICROSCAN SYNERGIES PLUS— 510(k) K020511

Substantially Equivalent

Dade Microscan, Inc.

FDA 510(k) clearance K020511 for MICROSCAN SYNERGIES PLUS, Substantially Equivalent on 2002-03-06. Applicant: Dade Microscan, Inc..

Clearance details

Applicant
Dade Microscan, 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.