OPUS(R) ROZO
FDA 510(k) clearance K911834 · decided 1991-08-12
Clearance details
- K-number
- K911834
- Device name
- OPUS(R) ROZO
- Applicant
- Pb Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-04-25
- Decision date
- 1991-08-12
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- LGD
- Device class
- 2
- Regulation number
- 866.3780
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Westwood, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.