IMMUNETECH TOTAL IGE SYSTEM
FDA 510(k) clearance K032251 · decided 2003-12-19
Clearance details
- K-number
- K032251
- Device name
- IMMUNETECH TOTAL IGE SYSTEM
- Applicant
- Immunetech Corporation
- Decision
- Substantially Equivalent
- Date received
- 2003-07-22
- Decision date
- 2003-12-19
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- DGC
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Rancho Santa Fe, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.