IGA IMMUNOTURBIDIMETRIC & CALIBRATOR— 510(k) K955794
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K955794 for IGA IMMUNOTURBIDIMETRIC & CALIBRATOR, Substantially Equivalent on 1996-04-05. Applicant: Randox Laboratories, Ltd.. Device class: 2.
Clearance details
- Applicant
- Randox Laboratories, Ltd.
- Product code
- Code CZP
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crumlin, IE
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More clearances from Randox Laboratories, Ltd.
view allRecalls naming K955794
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 K955794.
Data sourced from openFDA. This site is unofficial and independent of the FDA.