FIAX TOTAL IGE TEST KIT
FDA 510(k) clearance K842749 · decided 1984-08-28
Clearance details
- K-number
- K842749
- Device name
- FIAX TOTAL IGE TEST KIT
- Applicant
- Intl. Diagnostic Technology
- Decision
- Substantially Equivalent
- Date received
- 1984-07-13
- Decision date
- 1984-08-28
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- DGP
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VIDAS TOTAL IGE (IGE) ASSAY (K931224) | Biomerieux Vitek, Inc. | 1993-05-20 |
| IMMPULSE IGE ASSAY REAGENTS (K863327) | Sclavo, Inc. | 1986-12-03 |
| ALLERGENETICS ALLER-SPECIFIC IGE SERUM (K842969) | Allergenetics | 1984-08-28 |
Recalls involving this device
No recalls on record reference this clearance.