The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Ck-mb Assay.
| Device ID | K912766 |
| 510k Number | K912766 |
| Device Name: | AMERLITE CK-MB ASSAY |
| Classification | Colorimetric Method, Cpk Or Isoenzymes |
| Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Contact | Kathryn Patterson |
| Correspondent | Kathryn Patterson AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Product Code | JHY |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-24 |
| Decision Date | 1991-07-17 |