Randox Calibration Serum
FDA 510(k) K053153 · Randox Laboratories, Ltd.
510(k) numberK053153
Submission
- Device name
- Randox Calibration Serum
- Applicant
- Randox Laboratories, Ltd.
Crumlin, GB - Received
- November 10, 2005
- Decision date
- January 13, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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Questions and answers
When was Randox Calibration Serum cleared by the FDA?
Randox Calibration Serum (K053153) received a 510(k) decision of Substantially Equivalent on January 13, 2006, 64 days after the submission was received.
What is the product code of K053153?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.