EL-RF TEST SYSTEM: EL-RF-IGM KIT
FDA 510(k) clearance K933712 · decided 1994-01-28
Clearance details
- K-number
- K933712
- Device name
- EL-RF TEST SYSTEM: EL-RF-IGM KIT
- Applicant
- Theratest Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-07-30
- Decision date
- 1994-01-28
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- DHR
- Device class
- 2
- Regulation number
- 866.5775
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.