VITROS Immunodiagnostic Products Syphilis Reagent Pack— 510(k) K241534
Substantially EquivalentOrtho Clinical Diagnostics
FDA 510(k) clearance K241534 for VITROS Immunodiagnostic Products Syphilis Reagent Pack, Substantially Equivalent on 2024-08-28. Applicant: Ortho Clinical Diagnostics. Device class: 2.
Clearance details
- Applicant
- Ortho Clinical Diagnostics
- Product code
- Code LIP
- Device class
- Class 2
- Regulation
- 21 CFR 866.3830
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bridgend, GB
Recent devices under product code LIP
view allMore clearances from Ortho Clinical Diagnostics
view all- 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
- K221355 — VITROS Immuodiagnostic Products CA 125 II Reagent Pack
Data sourced from openFDA. This site is unofficial and independent of the FDA.