COBAS ALPHA
FDA 510(k) clearance K910222 · decided 1991-02-27
Clearance details
- K-number
- K910222
- Device name
- COBAS ALPHA
- Applicant
- Roche Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-01-18
- Decision date
- 1991-02-27
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- JJG
- Device class
- 1
- Regulation number
- 862.2140
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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.