BIO-RAD %CDT TIA— 510(k) K001651
Substantially EquivalentAxis-Shield Biochemicals, Asa
FDA 510(k) clearance K001651 for BIO-RAD %CDT TIA, Substantially Equivalent on 2000-11-22. Applicant: Axis-Shield Biochemicals, Asa.
Clearance details
- Applicant
- Axis-Shield Biochemicals, Asa
- Product code
- Code JJX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, 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.