510(k) K981985— ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209
Substantially EquivalentBeckman Coulter, Inc.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code DHX
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.