The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Imx(r) Stat Ck-mb.
| Device ID | K931172 |
| 510k Number | K931172 |
| Device Name: | IMX(R) STAT CK-MB |
| Classification | Colorimetric Method, Cpk Or Isoenzymes |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Joy C Sonsalla |
| Correspondent | Joy C Sonsalla ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | JHY |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-08 |
| Decision Date | 1993-06-15 |