VITROS Immunodiagnostic Products Intact PTH II Reagent Pack— 510(k) K221197
Substantially EquivalentOrtho Clinical Diagnostics
FDA 510(k) clearance K221197 for VITROS Immunodiagnostic Products Intact PTH II Reagent Pack, Substantially Equivalent on 2023-09-05. Applicant: Ortho Clinical Diagnostics. Device class: 2.
Clearance details
- Applicant
- Ortho Clinical Diagnostics
- Product code
- Code CEW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1545
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bridgend, GB
Recent devices under product code CEW
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
- 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
Adverse events under product code CEW
product code CEW- Malfunction
- 480
- Total
- 480
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.