BILIRUBIN CALIBRATORS— 510(k) K822334
Substantially EquivalentGilford Diagnostics
FDA 510(k) clearance K822334 for BILIRUBIN CALIBRATORS, Substantially Equivalent on 1982-09-02. Applicant: Gilford Diagnostics. Device class: 2.
Clearance details
- Applicant
- Gilford Diagnostics
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code JIT
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