510(k) K974721— UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
Substantially EquivalentBayer Corp.
Clearance details
- Applicant
- Bayer Corp.
- Product code
- Code CGI
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.