ALP IFCC Gen.2
FDA 510(k) K171080 · Roche Diagnostics Operations (Rdo)
510(k) numberK171080
Submission
- Device name
- ALP IFCC Gen.2
- Applicant
- Roche Diagnostics Operations (Rdo)
Indianapolis, IN, US - Received
- April 11, 2017
- Decision date
- May 10, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1050
- Specialty
- Clinical Chemistry
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Questions and answers
When was ALP IFCC Gen.2 cleared by the FDA?
ALP IFCC Gen.2 (K171080) received a 510(k) decision of Substantially Equivalent on May 10, 2017, 29 days after the submission was received.
What is the product code of K171080?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.