TOTAL BILIRUBIN TEST KIT— 510(k) K861998
Substantially EquivalentCiba Corning Diagnostics Corp.
FDA 510(k) clearance K861998 for TOTAL BILIRUBIN TEST KIT, Substantially Equivalent on 1986-06-27. Applicant: Ciba Corning Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Ciba Corning Diagnostics Corp.
- 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
- Oberlin, OH, US
Recent devices under product code CIG
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