The following data is part of a premarket notification filed by I-stat Corp. with the FDA for I-stat Portable Clinical Analyzer, Model 300.
| Device ID | K001387 |
| 510k Number | K001387 |
| Device Name: | I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 |
| Classification | Glucose Oxidase, Glucose |
| 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 | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-02 |
| Decision Date | 2000-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00054749001262 | K001387 | 000 |
| 00054749003709 | K001387 | 000 |
| 00054749003716 | K001387 | 000 |
| 00054749003723 | K001387 | 000 |
| 00054749003730 | K001387 | 000 |
| 00054749003747 | K001387 | 000 |
| 00054749003754 | K001387 | 000 |
| 00054749003761 | K001387 | 000 |
| 00054749003778 | K001387 | 000 |
| 00054749003853 | K001387 | 000 |
| 00054749003860 | K001387 | 000 |
| 00054749003877 | K001387 | 000 |
| 00054749003884 | K001387 | 000 |
| 00054749003891 | K001387 | 000 |
| 00054749003907 | K001387 | 000 |
| 00054749003914 | K001387 | 000 |
| 00054749003693 | K001387 | 000 |