The following data is part of a premarket notification filed by I-stat Corporation with the FDA for I-stat Creatine Kinase Mb (ck-mb).
| Device ID | K051433 |
| 510k Number | K051433 |
| Device Name: | I-STAT CREATINE KINASE MB (CK-MB) |
| Classification | Biosensor, Immunoassay, Cpk Or Isoenzymes |
| 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 | MYT |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-01 |
| Decision Date | 2005-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10054749000200 | K051433 | 000 |