IRMA TRUPOINT CREATININE CONTROL KIT— 510(k) K050983
Substantially EquivalentInternational Technidyne Corporation
FDA 510(k) clearance K050983 for IRMA TRUPOINT CREATININE CONTROL KIT, Substantially Equivalent on 2005-05-16. Applicant: International Technidyne Corporation.
Clearance details
- Applicant
- International Technidyne Corporation
- Product code
- Code JJX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roseville, MN, US
Adverse events under product code JJX
product code JJX- Other
- 2
- Total
- 2
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.