TDM CONTROL SET, MODEL CAT# 04521536— 510(k) K070200
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K070200 for TDM CONTROL SET, MODEL CAT# 04521536, Substantially Equivalent on 2007-03-19. Applicant: Roche Diagnostics Corp..
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code JJY
- 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.