K923258
Substantially EquivalentTECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE
- Applicant
- Heraeus Kulzer, Inc.
- Product code
- CDP
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Adverse events under product code CDP
product code CDP- Malfunction
- 647
- Total
- 647
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.