The following data is part of a premarket notification filed by I-stat Corporation with the FDA for I-stat Cardiac Troponin (ctni) Test.
| Device ID | K031739 |
| 510k Number | K031739 |
| Device Name: | I-STAT CARDIAC TROPONIN (CTNI) TEST |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | I-STAT CORPORATION 104 WINDSOR CENTER DR. East Windsor, NJ 08520 |
| Contact | Gregory W Shipp |
| Correspondent | Gregory W Shipp I-STAT CORPORATION 104 WINDSOR CENTER DR. East Windsor, NJ 08520 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-04 |
| Decision Date | 2003-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10054749000187 | K031739 | 000 |