510(k) K171080
K171080 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Operations (Rdo) for the device "ALP IFCC Gen.2". The FDA issued a decision of Substantially Equivalent on May 10, 2017. The device falls under product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Roche Diagnostics Operations (Rdo) has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2017
- Date Received
- April 11, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Device Class
- Class II
- Regulation Number
- 862.1050
- Review Panel
- CH
- Submission Type