READAR
FDA 510(k) clearance K925951 · decided 1993-08-31
Clearance details
- K-number
- K925951
- Device name
- READAR
- Applicant
- Alamar Biosciences Laboratory, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-11-24
- Decision date
- 1993-08-31
- Days to decision
- 280 days
- Clearance type
- Traditional
- Product code
- LRG
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sacramento, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.