CALIBRATION PACK, MODELS A9100-101S AND A9100-103S— 510(k) K023792
Substantially EquivalentThermo Orion
FDA 510(k) clearance K023792 for CALIBRATION PACK, MODELS A9100-101S AND A9100-103S, Substantially Equivalent on 2003-01-31. Applicant: Thermo Orion. Device class: 2.
Clearance details
- Applicant
- Thermo Orion
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beverly, MA, US
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