The following data is part of a premarket notification filed by I-stat Corporation with the FDA for I-stat Prothrombin Time Test.
| Device ID | K020355 |
| 510k Number | K020355 |
| Device Name: | I-STAT PROTHROMBIN TIME TEST |
| Classification | Test, Time, Prothrombin |
| Applicant | I-STAT CORPORATION 104 WINDSOR CENTER DR. East Windsor, NJ 08540 |
| Contact | Paul Vandererf |
| Correspondent | Paul Vandererf I-STAT CORPORATION 104 WINDSOR CENTER DR. East Windsor, NJ 08540 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-04 |
| Decision Date | 2002-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10054749000170 | K020355 | 000 |