VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS— 510(k) K060480
Substantially EquivalentOrtho-Clinical Diagnostics
FDA 510(k) clearance K060480 for VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS, Substantially Equivalent on 2006-07-03. Applicant: Ortho-Clinical Diagnostics. Device class: 2.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics
- Product code
- Code CGR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1205
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.