K781221

Substantially Equivalent

DILUTION KIT, THERMAL, COLD PAC

Applicant
Instrumentation Laboratory CO
Product code
DRC
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DRC

product code DRC
Death
28
Injury
412
Total
440

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.