Ace Calibrator
FDA 510(k) K141728 · SENTINEL CH. SpA
510(k) numberK141728
Submission
- Device name
- Ace Calibrator
- Applicant
- SENTINEL CH. SpA
Milan, IT - Received
- June 26, 2014
- Decision date
- July 28, 2014
- 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 Ace Calibrator cleared by the FDA?
Ace Calibrator (K141728) received a 510(k) decision of Substantially Equivalent on July 28, 2014, 32 days after the submission was received.
What is the product code of K141728?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.