IGM RF EIA
FDA 510(k) clearance K942908 · decided 1995-01-20
Clearance details
- K-number
- K942908
- Device name
- IGM RF EIA
- Applicant
- Sigma Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-06-21
- Decision date
- 1995-01-20
- Days to decision
- 213 days
- Clearance type
- Traditional
- Product code
- DHR
- Device class
- 2
- Regulation number
- 866.5775
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.