DeviceClearance

K001154

Substantially Equivalent

I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER

Applicant
I-Stat Corp.
Product code
JGS
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
East Windsor, NJ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code JGS

product code JGS
Malfunction
535
Total
535

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.