VITROS Immunodiagnostic Products Insulin Calibrators— 510(k) K171168
Substantially EquivalentOrtho Clinical Diagnostics
FDA 510(k) clearance K171168 for VITROS Immunodiagnostic Products Insulin Calibrators, Substantially Equivalent on 2017-05-16. Applicant: Ortho Clinical Diagnostics. Device class: 2.
Clearance details
- Applicant
- Ortho Clinical Diagnostics
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Rochester, NY, US
Recent devices under product code JIT
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Data sourced from openFDA. This site is unofficial and independent of the FDA.