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. Device class: 2.
Clearance details
- Applicant
- Orion Diagnostica, OY
- 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
- Special
- Location
- Espoo, FI
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