The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for I-stat Hematocrit Test With I-stat Alinity System.
| Device ID | K163342 |
| 510k Number | K163342 |
| Device Name: | I-STAT Hematocrit Test With I-STAT Alinity System |
| Classification | Device, Hematocrit Measuring |
| Applicant | Abbott Laboratories 400 College Road East Princeton, NJ 08540 |
| Contact | Tamara Mccaw |
| Correspondent | Laura Y. Joglekar Abbott Laboratories 400 College Road East Princeton, NJ 08540 |
| Product Code | JPI |
| CFR Regulation Number | 864.6400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-29 |
| Decision Date | 2017-08-22 |
| Summary: | summary |