K163342 is an FDA 510(k) clearance for the i-STAT Hematocrit test with i-STAT Alinity System. This device is classified as a Device, Hematocrit Measuring (Class II - Special Controls, product code JPI).
Submitted by Abbott Laboratories (Princton, US). The FDA issued a Cleared decision on August 22, 2017, 266 days after receiving the submission on November 29, 2016.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6400.
| 510(k) Number | K163342 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2016 |
| Decision Date | August 22, 2017 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JPI — Device, Hematocrit Measuring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6400 |