AMERLITE FERRITIN II ASSAY— 510(k) K952286
Substantially EquivalentJohnson & Johnson Clinical Diagnostics, Inc.
FDA 510(k) clearance K952286 for AMERLITE FERRITIN II ASSAY, Substantially Equivalent on 1995-06-20. Applicant: Johnson & Johnson Clinical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
- Product code
- Code DBF
- Device class
- Class 2
- Regulation
- 21 CFR 866.5340
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.