TOTAL BILIRUBIN REAGENT SET— 510(k) K040391
Substantially EquivalentPointe Scientific, Inc.,
FDA 510(k) clearance K040391 for TOTAL BILIRUBIN REAGENT SET, Substantially Equivalent on 2004-06-02. Applicant: Pointe Scientific, Inc.,.
Clearance details
- Applicant
- Pointe Scientific, Inc.,
- Product code
- Code CIG
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lincoln Park, MI, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.