The following data is part of a premarket notification filed by I-stat Corp. with the FDA for I-stat System.
| Device ID | K973292 |
| 510k Number | K973292 |
| Device Name: | I-STAT SYSTEM |
| Classification | Electrode, Ion Based, Enzymatic, Creatinine |
| Applicant | I-STAT CORP. 303 COLLEGE RD. EAST Princeton, NJ 08540 |
| Contact | Imants R Lauks |
| Correspondent | Imants R Lauks I-STAT CORP. 303 COLLEGE RD. EAST Princeton, NJ 08540 |
| Product Code | CGL |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-02 |
| Decision Date | 1997-10-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10054749000125 | K973292 | 000 |