K871196
Substantially EquivalentRHEUMA-CHECK ENZYME IMMUNOASSAY TEST
- Applicant
- Orion Diagnostica, Inc.
- Product code
- DHR
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerset, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.