The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas Tv/mg For Use On Cobas 6800/8800 Systems, Cobas Tv/mg Positive Control Kit, Cobas Buffer Negative Control Kit.
Device ID | K190433 |
510k Number | K190433 |
Device Name: | Cobas TV/MG For Use On Cobas 6800/8800 Systems, Cobas TV/MG Positive Control Kit, Cobas Buffer Negative Control Kit |
Classification | Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections |
Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 -2722 |
Contact | Nobuko Nakajima |
Correspondent | Nobuko Nakajima Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 -2722 |
Product Code | QEP |
CFR Regulation Number | 866.3393 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-02-22 |
Decision Date | 2019-05-22 |