The following data is part of a premarket notification filed by Dynagen, Inc. with the FDA for Mycoakt M Kansasii Culture Id Kit.
| Device ID | K943050 |
| 510k Number | K943050 |
| Device Name: | MYCOAKT M KANSASII CULTURE ID KIT |
| Classification | Kit, Identification, Mycobacteria |
| Applicant | DYNAGEN, INC. 99 ERIE ST. Cambridge, MA 02139 |
| Contact | Peter J Mione |
| Correspondent | Peter J Mione DYNAGEN, INC. 99 ERIE ST. Cambridge, MA 02139 |
| Product Code | JSY |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-27 |
| Decision Date | 1995-03-13 |