Direct LDL Cholesterol (LDL)
FDA 510(k) K161691 · Randox Laboratories Limited
510(k) numberK161691
Submission
- Device name
- Direct LDL Cholesterol (LDL)
- Applicant
- Randox Laboratories Limited
Crumlin, GB - Received
- June 20, 2016
- Decision date
- March 20, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRR – System, Test, Low Density, Lipoprotein
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
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Questions and answers
When was Direct LDL Cholesterol (LDL) cleared by the FDA?
Direct LDL Cholesterol (LDL) (K161691) received a 510(k) decision of Substantially Equivalent on March 20, 2017, 273 days after the submission was received.
What is the product code of K161691?
The FDA product code is MRR – System, Test, Low Density, Lipoprotein, a Class I (low risk) device regulated under 21 CFR 862.1475.