Randox Cystatin C Control Level 2 Randox Cystatin C Control Level 3
FDA 510(k) K121588 · Randox Laboratories, Ltd.
510(k) numberK121588
Submission
- Device name
- Randox Cystatin C Control Level 2 Randox Cystatin C Control Level 3
- Applicant
- Randox Laboratories, Ltd.
Crumlin, GB - Received
- May 31, 2012
- Decision date
- June 20, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Randox Cystatin C Control Level 2 Randox Cystatin C Control Level 3 cleared by the FDA?
Randox Cystatin C Control Level 2 Randox Cystatin C Control Level 3 (K121588) received a 510(k) decision of Substantially Equivalent on June 20, 2012, 20 days after the submission was received.
What is the product code of K121588?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.