VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack— 510(k) K201312
Substantially EquivalentOrtho Clinical Diagnostics
FDA 510(k) clearance K201312 for VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack, Substantially Equivalent on 2021-10-04. Applicant: Ortho Clinical Diagnostics. Device class: 2.
Clearance details
- Applicant
- Ortho Clinical Diagnostics
- Product code
- Code NBC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1117
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code NBC
view allMore clearances from Ortho Clinical Diagnostics
view all- K241534 — VITROS Immunodiagnostic Products Syphilis Reagent Pack
- K233581 — VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
- K221197 — VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
- K231517 — VITROS Immunodiagnostic Products CEA Reagent Pack
- K231525 — VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
Data sourced from openFDA. This site is unofficial and independent of the FDA.