K961824
Substantially EquivalentCOBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- DCF
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerville, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.