RANDOX IGE— 510(k) K010855
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K010855 for RANDOX IGE, Substantially Equivalent on 2001-05-15. Applicant: Randox Laboratories, Ltd.. Device class: 2.
Clearance details
- Applicant
- Randox Laboratories, Ltd.
- Product code
- Code DGC
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crumlin, Co. Antrim, GB
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More clearances from Randox Laboratories, Ltd.
view allRecalls naming K010855
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 K010855.
Data sourced from openFDA. This site is unofficial and independent of the FDA.