Randox Aldolase Calibration Serum
FDA 510(k) K142181 · Randox Laboratories Limited
510(k) numberK142181
Submission
- Device name
- Randox Aldolase Calibration Serum
- Applicant
- Randox Laboratories Limited
Crumlin, GB - Received
- August 8, 2014
- Decision date
- September 18, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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Questions and answers
When was Randox Aldolase Calibration Serum cleared by the FDA?
Randox Aldolase Calibration Serum (K142181) received a 510(k) decision of Substantially Equivalent on September 18, 2014, 41 days after the submission was received.
What is the product code of K142181?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.