510(k) DEN190016
- Device
- cobas vivoDx MRSA
- Applicant
- Roche Molecular Systems, Inc.
- 510(k) number
- DEN190016
- Product code
- QIV
- Decision
- Unknown (DENG)
- Decision date
- 2019-12-05
- Date received
- 2019-03-19
- Regulation
- 866.1655
- Classification name
- Culture-Based Short-Term Incubation Antimicrobial Resistance Assay
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Nobuko Nakajima
- Address
- 4300 Hacienda Dr. Pleasanton CA US 94588 94588
FDA Registration Numbers#
- 2243471
- 3004141078
Source Documents#
510(k) summary PDF not indicated by FDA