The following data is part of a premarket notification filed by Mec Dynamics Corp with the FDA for Avie A1c Test System.
| Device ID | K093548 |
| 510k Number | K093548 |
| Device Name: | AVIE A1C TEST SYSTEM |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | MEC DYNAMICS CORP 90 ROSE ORCHARD WAY San Jose, CA 95134 |
| Contact | Emmanuel Mpock |
| Correspondent | Emmanuel Mpock MEC DYNAMICS CORP 90 ROSE ORCHARD WAY San Jose, CA 95134 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-17 |
| Decision Date | 2011-07-20 |
| Summary: | summary |