VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY— 510(k) K983031
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K983031 for VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY, Substantially Equivalent on 1998-12-18. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code LOJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
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Recalls naming K983031
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983031.
Data sourced from openFDA. This site is unofficial and independent of the FDA.