The following data is part of a premarket notification filed by Quantech Ltd. with the FDA for Quantech Ck-mb Assay.
| Device ID | K984433 |
| 510k Number | K984433 |
| Device Name: | QUANTECH CK-MB ASSAY |
| Classification | Biosensor, Immunoassay, Cpk Or Isoenzymes |
| Applicant | QUANTECH LTD. 9418 LASAINE AVE. Northridge, CA 91325 |
| Contact | Robin J Hellen |
| Correspondent | Robin J Hellen QUANTECH LTD. 9418 LASAINE AVE. Northridge, CA 91325 |
| Product Code | MYT |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-14 |
| Decision Date | 1999-11-01 |
| Summary: | summary |