ONTRAK TESTCUP PRO-5, MODEL 1986678— 510(k) K001356
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K001356 for ONTRAK TESTCUP PRO-5, MODEL 1986678, Substantially Equivalent on 2000-07-10. Applicant: Roche Diagnostics Corp..
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code DJC
- Advisory panel
- Clinical Toxicology
- 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.