ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR— 510(k) K030003
Substantially EquivalentElan Diagnostics
FDA 510(k) clearance K030003 for ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR, Substantially Equivalent on 2003-09-29. Applicant: Elan Diagnostics.
Clearance details
- Applicant
- Elan Diagnostics
- Product code
- Code CIG
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.