K171080 is an FDA 510(k) clearance for the ALP IFCC Gen.2. This device is classified as a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II - Special Controls, product code CJE).
Submitted by Roche Diagnostics Operations (Rdo) (Indianapolis, US). The FDA issued a Cleared decision on May 10, 2017, 29 days after receiving the submission on April 11, 2017.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1050.
| 510(k) Number | K171080 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2017 |
| Decision Date | May 10, 2017 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CJE — Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1050 |