K153286 is an FDA 510(k) clearance for the iHealth Align Gluco-Monitoring system. This device is classified as a System, Test, Blood Glucose, Over The Counter (Class II - Special Controls, product code NBW).
Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on August 19, 2016, 281 days after receiving the submission on November 12, 2015.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K153286 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2015 |
| Decision Date | August 19, 2016 |
| Days to Decision | 281 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NBW — System, Test, Blood Glucose, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |