VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS— 510(k) K993068
Substantially EquivalentOrtho-Clinical Diagnostics
FDA 510(k) clearance K993068 for VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS, Substantially Equivalent on 1999-10-04. Applicant: Ortho-Clinical Diagnostics. Device class: 2.
Clearance details
- Device name as filed
- VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS
- Applicant
- Ortho-Clinical Diagnostics
- Product code
- Code JHX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rochester, NY, US
Recent devices under product code JHX
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- K120326 — AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE
- K081360 — PATHFAST CK-MB-II, PATHFAST MYO-II
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Data sourced from openFDA. This site is unofficial and independent of the FDA.