MODIFICATION TO MYALLERGY TEST
FDA 510(k) clearance K061979 · decided 2006-09-22
Clearance details
- K-number
- K061979
- Device name
- MODIFICATION TO MYALLERGY TEST
- Applicant
- Immunetech Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-07-13
- Decision date
- 2006-09-22
- Days to decision
- 71 days
- Clearance type
- Special
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Menlo Park, CA, US
- Third-party review
- No
- Expedited review
- No
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