The following data is part of a premarket notification filed by I-stat Corporation with the FDA for I-stat B-type Natriuretic Peptide (bnp).
| Device ID | K053597 |
| 510k Number | K053597 |
| Device Name: | I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) |
| Classification | Test, Natriuretic Peptide |
| Applicant | I-STAT CORPORATION 104 WINDSOR CENTER DRIVE East Windsor, NJ 08520 |
| Contact | Sue Kent |
| Correspondent | Sue Kent I-STAT CORPORATION 104 WINDSOR CENTER DRIVE East Windsor, NJ 08520 |
| Product Code | NBC |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-23 |
| Decision Date | 2006-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10054749000217 | K053597 | 000 |