The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Ck-mb Stat.
| Device ID | K974421 |
| 510k Number | K974421 |
| Device Name: | ELECSYS CK-MB STAT |
| Classification | Colorimetric Method, Cpk Or Isoenzymes |
| Applicant | BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Contact | Jody J Savage |
| Correspondent | Jody J Savage BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Product Code | JHY |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-24 |
| Decision Date | 1997-12-17 |
| Summary: | summary |