ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET— 510(k) K052982
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K052982 for ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET, Substantially Equivalent on 2005-10-28. Applicant: Roche Diagnostics.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code JIT
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Indianapolis, IN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.