ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257— 510(k) K022176
Substantially EquivalentOrion Diagnostica, Div. Orion Corp.
FDA 510(k) clearance K022176 for ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257, Substantially Equivalent on 2002-12-03. Applicant: Orion Diagnostica, Div. Orion Corp.. Device class: 2.
Clearance details
- Applicant
- Orion Diagnostica, Div. Orion Corp.
- Product code
- Code DCK
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Espoo, FI
Recent devices under product code DCK
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