SM EIA TEST KIT
FDA 510(k) clearance K935414 · decided 1994-05-02
Clearance details
- K-number
- K935414
- Device name
- SM EIA TEST KIT
- Applicant
- David A. Fuccillo, Ph.D.
- Decision
- Substantially Equivalent
- Date received
- 1993-11-09
- Decision date
- 1994-05-02
- Days to decision
- 174 days
- Clearance type
- Traditional
- Product code
- LJM
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Washington, D.C., DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.