510(k) K822942— INNOTRON FLUORIMETER SERIES ONE-10

Substantially Equivalent

Innotron of Oregon, Inc.

Clearance details

Applicant
Innotron of Oregon, Inc.
Product code
Code KHO
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KHO

product code KHO
Malfunction
1,339
Total
1,339

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.