The following data is part of a premarket notification filed by Abbott Point Of Care Inc. with the FDA for I-stat Alinity System With I-stat Sodium Test.
| Device ID | K153357 |
| 510k Number | K153357 |
| Device Name: | I-STAT Alinity System With I-STAT Sodium Test |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | ABBOTT POINT OF CARE INC. 400 COLLEGE ROAD EAST Princeton, NJ 08540 |
| Contact | Melissa Robinson |
| Correspondent | Melissa Robinson ABBOTT POINT OF CARE INC. 400 COLLEGE ROAD EAST Princeton, NJ 08540 |
| Product Code | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-20 |
| Decision Date | 2016-07-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00054749004393 | K153357 | 000 |
| 00054749004386 | K153357 | 000 |
| 00054749004379 | K153357 | 000 |
| 00054749002597 | K153357 | 000 |