ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE)— 510(k) K912318
Substantially EquivalentSerono-Baker Diagnostics, Inc.
FDA 510(k) clearance K912318 for ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE), Substantially Equivalent on 1991-07-25. Applicant: Serono-Baker Diagnostics, Inc..
Clearance details
- Applicant
- Serono-Baker Diagnostics, Inc.
- Product code
- Code CHP
- 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.