ACL TOP 970 CL— 510(k) K233790
Substantially EquivalentInstrumentation Laboratory
FDA 510(k) clearance K233790 for ACL TOP 970 CL, Substantially Equivalent on 2023-12-29. Applicant: Instrumentation Laboratory.
Clearance details
- Applicant
- Instrumentation Laboratory
- Product code
- Code JPA
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bedford, MA, US
Adverse events under product code JPA
product code JPA- Death
- 6
- Total
- 6
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.