510(k) K780508— QUANTITOPE 125I-FOLATE RADIOASSAY KIT
Substantially EquivalentKallestad Laboratories, Inc.
Clearance details
- Applicant
- Kallestad Laboratories, Inc.
- Product code
- Code CGN
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.