K984138
Substantially EquivalentAPTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM
- Applicant
- Zeus Scientific, Inc.
- Product code
- LSR
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.