The following data is part of a premarket notification filed by I-stat Corp. with the FDA for I-stat System.
| Device ID | K011478 |
| 510k Number | K011478 |
| Device Name: | I-STAT SYSTEM |
| Classification | Acid, Lactic, Enzymatic Method |
| Applicant | I-STAT CORP. 104 WINDSOR CENTER DR. East Windsor, NJ 08520 |
| Contact | Paul Vanderwerf |
| Correspondent | Paul Vanderwerf I-STAT CORP. 104 WINDSOR CENTER DR. East Windsor, NJ 08520 |
| Product Code | KHP |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGL |
| Subsequent Product Code | CHL |
| CFR Regulation Number | 862.1450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-14 |
| Decision Date | 2001-07-02 |