EL-RF/3 (IGM-IGG-IGA) KIT
FDA 510(k) clearance K941398 · decided 1995-07-28
Clearance details
- K-number
- K941398
- Device name
- EL-RF/3 (IGM-IGG-IGA) KIT
- Applicant
- Theratest Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-03-22
- Decision date
- 1995-07-28
- Days to decision
- 493 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
| Record | Firm | Date |
|---|---|---|
| RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro diag recall (Z-1546-2012) | Thera Test Laboratories, Inc. | 2012-05-14 |