The following data is part of a premarket notification filed by Hellen Professional Services with the FDA for Quantech Myoglobin Assay.
| Device ID | K981536 |
| 510k Number | K981536 |
| Device Name: | QUANTECH MYOGLOBIN ASSAY |
| Classification | Biosensor, Immunoassay, Myoglobin |
| Applicant | HELLEN PROFESSIONAL SERVICES 9418 LASAINE AVE. Northridge, CA 91325 |
| Contact | Robin J Hellen |
| Correspondent | Robin J Hellen HELLEN PROFESSIONAL SERVICES 9418 LASAINE AVE. Northridge, CA 91325 |
| Product Code | MVE |
| CFR Regulation Number | 866.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-29 |
| Decision Date | 1998-06-29 |
| Summary: | summary |