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 |