COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR— 510(k) K141928
Substantially EquivalentRoche Diagnostics Operations (Rdo)
FDA 510(k) clearance K141928 for COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR, Substantially Equivalent on 2014-11-25. Applicant: Roche Diagnostics Operations (Rdo).
Clearance details
- Applicant
- Roche Diagnostics Operations (Rdo)
- Product code
- Code DKB
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.