i-STAT Alinity System with i-STAT Sodium test— 510(k) K153357
Substantially EquivalentAbbott Point of Care, Inc.
FDA 510(k) clearance K153357 for i-STAT Alinity System with i-STAT Sodium test, Substantially Equivalent on 2016-07-08. Applicant: Abbott Point of Care, Inc..
Clearance details
- Applicant
- Abbott Point of Care, Inc.
- Product code
- Code JGS
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Princton, NJ, US
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.