C-REACTIVE PROTEIN LATEX KIT— 510(k) K954447
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K954447 for C-REACTIVE PROTEIN LATEX KIT, Substantially Equivalent on 1995-12-18. Applicant: Randox Laboratories, Ltd.. Device class: 2.
Clearance details
- Applicant
- Randox Laboratories, Ltd.
- Product code
- Code DCK
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crumlin, IE
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