The following data is part of a premarket notification filed by Miacom Diagnostics Gmbh with the FDA for Hemofish Masterpanel.
| Device ID | K150031 |
| 510k Number | K150031 |
| Device Name: | HemoFISH Masterpanel |
| Classification | Kit, Identification, Enterobacteriaceae |
| Applicant | MIACOM DIAGNOSTICS GMBH MEROWINGERPLATZ 1A Dusseldorf, DE 40225 |
| Contact | Eve Blomeke |
| Correspondent | Eve Blomeke MIACOM DIAGNOSTICS GMBH MEROWINGERPLATZ 1A Dusseldorf, DE 40225 |
| Product Code | JSS |
| Subsequent Product Code | MCS |
| Subsequent Product Code | MDK |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-08 |
| Decision Date | 2015-10-01 |
| Summary: | summary |