STANBIO BILIRUBIN TEST SET— 510(k) K810055
Substantially EquivalentStanbio Laboratory
FDA 510(k) clearance K810055 for STANBIO BILIRUBIN TEST SET, Substantially Equivalent on 1981-02-02. Applicant: Stanbio Laboratory. Device class: 2.
Clearance details
- Applicant
- Stanbio Laboratory
- 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
- Mchenry, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.