cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit— 510(k) K190433
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K190433 for cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit, Substantially Equivalent on 2019-05-22. Applicant: Roche Molecular Systems, Inc..
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Code QEP
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.