510(k) K955102— BIODATA TESTOSTERONE MAIA KIT
Substantially EquivalentBiochem Immunosystems (U.S.), Inc.
Clearance details
- Applicant
- Biochem Immunosystems (U.S.), Inc.
- Product code
- Code CDZ
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Allentown, PA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.