510(k) K984135— THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
Substantially EquivalentZeus Scientific, Inc.
Clearance details
- Applicant
- Zeus Scientific, Inc.
- Product code
- Code GQL
- 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.