REDI-SCREEN
FDA 510(k) clearance K993100 · decided 1999-10-06
Clearance details
- K-number
- K993100
- Device name
- REDI-SCREEN
- Applicant
- Redwood Biotech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-09-16
- Decision date
- 1999-10-06
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- DJC
- Device class
- 2
- Regulation number
- 862.3610
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mountian View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.