ENCORE SS-A
FDA 510(k) clearance K922157 · decided 1992-10-13
Clearance details
- K-number
- K922157
- Device name
- ENCORE SS-A
- Applicant
- Clark Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-05-07
- Decision date
- 1992-10-13
- Days to decision
- 159 days
- Clearance type
- Traditional
- Product code
- LLL
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Blairstown, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.