Randox Lipoprotein
FDA 510(k) K011568 · Randox Laboratories, Ltd.
510(k) numberK011568
Submission
- Device name
- Randox Lipoprotein
- Applicant
- Randox Laboratories, Ltd.
Crumlin, GB - Received
- May 21, 2001
- Decision date
- September 28, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JIS – Calibrator, Primary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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| K032296 | Vitros Immunodiagnostic Products Progestrone Reagent Pack and CalibratorsJIS · Special | Ortho-Clinical Diagnostics, Inc. | 08/13/2003SE |
| K030964 | Calibration Plasma LMW HeparinJIS · Traditional | Instrumentation Laboratory CO | 06/06/2003SE |
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Questions and answers
When was Randox Lipoprotein cleared by the FDA?
Randox Lipoprotein (K011568) received a 510(k) decision of Substantially Equivalent on September 28, 2001, 130 days after the submission was received.
What is the product code of K011568?
The FDA product code is JIS – Calibrator, Primary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.