The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Bact/alert 3d Microbial Detection System.
Device ID | K981736 |
510k Number | K981736 |
Device Name: | BACT/ALERT 3D MICROBIAL DETECTION SYSTEM |
Classification | System, Blood Culturing |
Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
Contact | Rebecca A Rivas |
Correspondent | Rebecca A Rivas 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 | 1998-05-18 |
Decision Date | 1998-07-24 |
Summary: | summary |