The following data is part of a premarket notification filed by I-stat Corp. with the FDA for Model 100 Portable Clinical Analyzer And Test Pack.
| Device ID | K894914 |
| 510k Number | K894914 |
| Device Name: | MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | I-STAT CORP. 303 COLLEGE RD. EAST Princeton, NJ 08540 |
| Contact | Michael Groves |
| Correspondent | Michael Groves 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 | 1989-08-02 |
| Decision Date | 1989-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10054749000118 | K894914 | 000 |