510(k) K770458— BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR.
Substantially EquivalentIcn Pharmaceuticals, Inc.
Clearance details
- Applicant
- Icn Pharmaceuticals, Inc.
- Product code
- Code CIG
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orangeburg, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.