The following data is part of a premarket notification filed by I-stat Corp. with the FDA for I-stat Control Levels 1,2,3.
| Device ID | K934641 |
| 510k Number | K934641 |
| Device Name: | I-STAT CONTROL LEVELS 1,2,3 |
| Classification | Electrolyte Controls (assayed And Unassayed) |
| Applicant | I-STAT CORP. 303 COLLEGE RD. EAST Princeton, NJ 08540 |
| Contact | Robert F Martin |
| Correspondent | Robert F Martin I-STAT CORP. 303 COLLEGE RD. EAST Princeton, NJ 08540 |
| Product Code | JJR |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-21 |
| Decision Date | 1993-12-09 |