RANDOX HAEMOGLOBIN A1C— 510(k) K021897
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K021897 for RANDOX HAEMOGLOBIN A1C, Substantially Equivalent on 2002-11-26. Applicant: Randox Laboratories, Ltd.. Device class: 2.
Clearance details
- Applicant
- Randox Laboratories, Ltd.
- Product code
- Code LCP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7470
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crumlin, IE
Recent devices under product code LCP
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view allRecalls naming K021897
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 K021897.
Data sourced from openFDA. This site is unofficial and independent of the FDA.