K974189
Substantially EquivalentELECSYS PSA (ON ELECSYS 1010)
- Applicant
- Boehringer Mannheim Corp.
- Product code
- LTJ
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.