510(k) K001393— THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR
Substantially EquivalentZeus Scientific, Inc.
Clearance details
- Applicant
- Zeus Scientific, Inc.
- Product code
- Code MST
- Advisory panel
- Immunology
- 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.