QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE— 510(k) K042442
Substantially EquivalentOrion Diagnostica, OY
FDA 510(k) clearance K042442 for QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE, Substantially Equivalent on 2004-09-24. Applicant: Orion Diagnostica, OY.
Clearance details
- Applicant
- Orion Diagnostica, OY
- Product code
- Code DCK
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Espoo, FI
Data sourced from openFDA. This site is unofficial and independent of the FDA.