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.. Device class: 2.
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Product code QEP
- Device class
- Class 2
- Regulation
- 21 CFR 866.3393
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code QEP
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