The following data is part of a premarket notification filed by I-stat Corp. with the FDA for I-stat System.
| Device ID | K992571 |
| 510k Number | K992571 |
| Device Name: | I-STAT SYSTEM |
| Classification | Activated Whole Blood Clotting Time |
| 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 | JBP |
| CFR Regulation Number | 864.7140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-02 |
| Decision Date | 2000-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10054749000149 | K992571 | 000 |