ROCHE COBAS ARGOS 5 DIFF
FDA 510(k) clearance K912615 · decided 1991-09-27
Clearance details
- K-number
- K912615
- Device name
- ROCHE COBAS ARGOS 5 DIFF
- Applicant
- Roche Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-06-13
- Decision date
- 1991-09-27
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- GZI
- Device class
- 2
- Regulation number
- 882.5810
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Montclair, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.