COBAS 4800 CT / NG TEST
FDA 510(k) clearance K110923 · decided 2012-01-24
Clearance details
- K-number
- K110923
- Device name
- COBAS 4800 CT / NG TEST
- Applicant
- Roche Molecular Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-04-01
- Decision date
- 2012-01-24
- Days to decision
- 298 days
- Clearance type
- Traditional
- Product code
- MKZ
- Device class
- 1
- Regulation number
- 866.3120
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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