The following data is part of a premarket notification filed by I-stat Corp. with the FDA for I-stat Model 100 Port Clin Analyzer & Test Pack.
| Device ID | K912387 |
| 510k Number | K912387 |
| Device Name: | I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK |
| Classification | Electrode, Ion Specific, Sodium |
| 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 | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-01 |
| Decision Date | 1991-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10054749000088 | K912387 | 000 |