HEMOSIL READIPLAS TIN— 510(k) K122584
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K122584 for HEMOSIL READIPLAS TIN, Substantially Equivalent on 2013-03-24. Applicant: Instrumentation Laboratory CO.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code GJS
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Adverse events under product code GJS
product code GJS- Death
- 4
- Injury
- 229
- Malfunction
- 4,852
- Total
- 5,085
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.