The following data is part of a premarket notification filed by Mec Dynamics Corp with the FDA for Avie Total Hb Test System.
| Device ID | K121752 |
| 510k Number | K121752 |
| Device Name: | AVIE TOTAL HB TEST SYSTEM |
| Classification | System, Hemoglobin, Automated |
| Applicant | MEC DYNAMICS CORP 90 ROSE ORCHARD WAY San Jose, CA 95134 |
| Contact | Emmanual Mpock |
| Correspondent | Emmanual Mpock MEC DYNAMICS CORP 90 ROSE ORCHARD WAY San Jose, CA 95134 |
| Product Code | GKR |
| CFR Regulation Number | 864.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-14 |
| Decision Date | 2013-01-07 |
| Summary: | summary |