VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS— 510(k) K011250
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K011250 for VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS, Substantially Equivalent on 2001-06-13. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code JJX
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
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Adverse events under product code JJX
product code JJX- Other
- 2
- Total
- 2
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.