ELECSYS LH CALSET II— 510(k) K031299
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K031299 for ELECSYS LH CALSET II, Substantially Equivalent on 2003-05-12. Applicant: Roche Diagnostics Corp..
Clearance details
- Applicant
- Roche Diagnostics Corp.
- 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.