The following data is part of a premarket notification filed by I-stat Corporation with the FDA for I-stat Chem8 + Cartridge.
| Device ID | K053110 |
| 510k Number | K053110 |
| Device Name: | I-STAT CHEM8 + CARTRIDGE |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | I-STAT CORPORATION 104 WINDSOR CENTER DRIVE East Windsor, NJ 08520 |
| Contact | Paul Vanderwerf |
| Correspondent | Paul Vanderwerf I-STAT CORPORATION 104 WINDSOR CENTER DRIVE East Windsor, NJ 08520 |
| Product Code | JGS |
| Subsequent Product Code | CDS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGL |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JFL |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JPI |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-04 |
| Decision Date | 2006-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10054749001917 | K053110 | 000 |