The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Mb/bact Mycrobacteria Detection System.
| Device ID | K954468 |
| 510k Number | K954468 |
| Device Name: | MB/BACT MYCROBACTERIA DETECTION SYSTEM |
| Classification | System, Blood Culturing |
| Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Contact | Ann M Quinn |
| Correspondent | Ann M Quinn ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Product Code | MDB |
| CFR Regulation Number | 866.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-26 |
| Decision Date | 1996-07-22 |
| Summary: | summary |