COULTER DIRECT BILLRUBIN REAGENT— 510(k) K905622
Substantially EquivalentCoulter Electronics, Inc.
FDA 510(k) clearance K905622 for COULTER DIRECT BILLRUBIN REAGENT, Substantially Equivalent on 1990-12-26. Applicant: Coulter Electronics, Inc.. Device class: 2.
Clearance details
- Applicant
- Coulter Electronics, Inc.
- Product code
- Code CIG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1110
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hialeah, FL, US
Recent devices under product code CIG
view allMore clearances from Coulter Electronics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.