Lp(A) Calibrators, and Lp(A) Controls
FDA 510(k) K132400 · Biokit, S.A.
510(k) numberK132400
Submission
- Device name
- Lp(A) Calibrators, and Lp(A) Controls
- Applicant
- Biokit, S.A.
Llissa D'Amunt, Barcelona, ES - Received
- August 1, 2013
- Decision date
- December 19, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 Lp(A) Calibrators, and Lp(A) Controls cleared by the FDA?
Lp(A) Calibrators, and Lp(A) Controls (K132400) received a 510(k) decision of Substantially Equivalent on December 19, 2013, 140 days after the submission was received.
What is the product code of K132400?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.