IMMPULSE IGE ASSAY REAGENTS
FDA 510(k) clearance K863327 · decided 1986-12-03
Clearance details
- K-number
- K863327
- Device name
- IMMPULSE IGE ASSAY REAGENTS
- Applicant
- Sclavo, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-08-27
- Decision date
- 1986-12-03
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- DGP
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Sunnyvale, CA, 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 |
| ALLERGENETICS ALLER-SPECIFIC IGE SERUM (K842969) | Allergenetics | 1984-08-28 |
| FIAX TOTAL IGE TEST KIT (K842749) | Intl. Diagnostic Technology | 1984-08-28 |
Recalls involving this device
No recalls on record reference this clearance.