VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668— 510(k) K061464
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K061464 for VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668, Substantially Equivalent on 2006-06-15. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code JMO
- Device class
- Class 1
- Regulation
- 21 CFR 862.1415
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rochester, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.