VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack— 510(k) K231525
Substantially EquivalentOrtho Clinical Diagnostics
FDA 510(k) clearance K231525 for VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack, Substantially Equivalent on 2023-08-09. Applicant: Ortho Clinical Diagnostics. Device class: 2.
Clearance details
- Applicant
- Ortho Clinical Diagnostics
- Product code
- Code NIG
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bridgend, GB
Recent devices under product code NIG
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- 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
- K221355 — VITROS Immuodiagnostic Products CA 125 II Reagent Pack
Adverse events under product code NIG
product code NIG- Malfunction
- 618
- Total
- 618
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.