TOTAL BILIRUBIN REAGENT SET— 510(k) K821197
Substantially EquivalentOmega Medical Electronics
FDA 510(k) clearance K821197 for TOTAL BILIRUBIN REAGENT SET, Substantially Equivalent on 1982-07-13. Applicant: Omega Medical Electronics.
Clearance details
- Applicant
- Omega Medical Electronics
- Product code
- Code CIG
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.