ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS— 510(k) K912087
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K912087 for ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS, Substantially Equivalent on 1991-09-19. Applicant: Instrumentation Laboratory CO.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code JPA
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lexington, 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.